Hand, External Limb Component, Powered

Who Makes This Device Type in China?

6 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Shanghai and Jiangsu. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

AID United International Co., Limited Shanghai
Fortune Company Ltd. Guangdong, contract manufacturer
Foshan Hongfeng Co., Ltd. Guangdong, contract manufacturer
Medex Medical Supplies Ltd. Guangdong, contract manufacturer
Oymotion Technologies Co., Ltd. Shanghai
Yangzhou Sensport Healthcare Supplies Co., Ltd. Jiangsu

What Is FDA Product Code IQZ?

Hand, External Limb Component, Powered is FDA product code IQZ, Class 1, 21 CFR 890.3420.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

What Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2005. None was by a company in China. 1 is Class I, the most serious grade.

The root cause the FDA records most often is Device Design (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Hand, External Limb Component, Powered

Taska CX Hand – 7 3/4 LH LP – Black

Catalogue number TASKA-C2CB31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

ThunderCell Battery Lamination Kit

Catalogue number MKEB01, listed by Bionit Labs Srl, Italy, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska CX Hand – 7 3/4 RH QD – Black

Catalogue number TASKA-C1FB31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 8 1/4 RH LP White

Catalogue number TASKA-B1CA21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 7 3/4 LH QWD Black

Catalogue number TASKA-C2FB21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 7 3/4 RH QWD White

Catalogue number TASKA-C1FA21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 7 3/4 RH QWD Sand

Catalogue number TASKA-C1FC21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 8 1/4 LH LP Sand

Catalogue number TASKA-B2CC21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska CX Hand – 7 3/4 RH QD – Sand

Catalogue number TASKA-C1FC31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 8 1/4 LH QWD Sand

Catalogue number TASKA-B2FC21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska CX Hand – 7 1/4 RH QD – Sand

Catalogue number TASKA-D1FC31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska CX Hand – 7 1/4 LH LP – Black

Catalogue number TASKA-D2CB31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska CX Hand – 7 3/4 LH QD – Black

Catalogue number TASKA-C2FB31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska CX Hand – 7 3/4 RH LP – Sand

Catalogue number TASKA-C1CC31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska CX Hand – 7 1/4 LH LP – Sand

Catalogue number TASKA-D2CC31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Low Profile Lamination Kit

Catalogue number 152-20-031, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska CX Hand – 7 1/4 LH QD – Sand

Catalogue number TASKA-D2FC31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 8 1/4 LH LP Black

Catalogue number TASKA-B2CB21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska CX Hand – 7 3/4 LH QD – Sand

Catalogue number TASKA-C2FC31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 7 3/4 LH LP White

Catalogue number TASKA-C2CA21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Wrist Seal

Wrist Seal - Wrist Seal for Adam's Hand (spare part)

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 8 1/4 RH LP Sand

Catalogue number TASKA-B1CC21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

MyoLogic Pro

Software for configuring and customizing the Adam’s Hand device, designed for the orthopedic technician

Hand, External Limb Component, Powered

Taska CX Hand – 7 3/4 RH LP – Black

Catalogue number TASKA-C1CB31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska CX Hand – 7 1/4 RH LP – Black

Catalogue number TASKA-D1CB31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 8 1/4 RH QWD Sand

Catalogue number TASKA-B1FC21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 8 1/4 RH QWD Black

Catalogue number TASKA-B1FB21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

ThunderCell Battery Receptacle and Cable+Lamination Kit

ThunderCell Battery Receptacle and Cable - Beige - 20 cm + Lamination Kit

Hand, External Limb Component, Powered

Taska Battery Y-Cable

Catalogue number 152-00-064, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 7 3/4 LH QWD White

Catalogue number TASKA-C2FA21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska CX Hand – 7 1/4 LH QD – Black

Catalogue number TASKA-D2FB31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

ThunderCell Battery Receptacle and Cable

ThunderCell Battery Receptacle and Cable - Beige - 20 cm

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 7 3/4 RH LP Black

Catalogue number TASKA-C1CB21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 7 3/4 LH LP Sand

Catalogue number TASKA-C2CC21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska PowerCore System, Black

Catalogue number TASKA-21AB31, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Wrist

2 catalogue numbers from Hand Connection Plate 50mm, listed by Hugh Steeper Ltd, United Kingdom, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Pulse Pack

Pulse Hub - Vibratory Unit

Hand, External Limb Component, Powered

Taska CX Hand – 7 1/4 RH QD – Black

Catalogue number TASKA-D1FB31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 7 3/4 LH LP Black

Catalogue number TASKA-C2CB21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Short Wrist Lamination Kit

Short Wrist Lamination Kit 45 mm

Hand, External Limb Component, Powered

MyoLogic

Software for configuring and customizing the Adam’s Hand device, designed for the end user

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 8 1/4 RH QWD White

Catalogue number TASKA-B1FA21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 7 3/4 RH LP Sand

Catalogue number TASKA-C1CC21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska PowerCore System, Sand

Catalogue number TASKA-21AC31, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Analog Amplifier With Accessories

Analog Amplifier, 60 Hz with accessories - cable length 100 cm

Hand, External Limb Component, Powered

Esper Bionics

4 catalogue numbers from Size L, listed by Esper, TOV, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Adam’s Hand – Loaner

Adam's Hand - Loaner - Right, Medium, White, QDW (device)

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 8 1/4 LH QWD Black

Catalogue number TASKA-B2FB21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 7 3/4 RH LP White

Catalogue number TASKA-C1CA21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 7 3/4 RH QWD Black

Catalogue number TASKA-C1FB21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 8 1/4 LH LP White

Catalogue number TASKA-B2CA21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Zeus

ZeusV1 is designed for mild to moderate activities. Zeus v1 is an external prosthetic hand intended to be used with other appropriate upper limb components to form a complete arm…

Hand, External Limb Component, Powered

Wrist Lamination Kit

Wrist Lamination Kit 45 mm (QDW)

Hand, External Limb Component, Powered

Aether Battery System

The Battery system is a device which allows supply an energy to prosthetic hand . The Aether Battery System consists of a battery pack AET-BAT with the necessary interconnections.

Hand, External Limb Component, Powered

Taska CX Hand – 7 3/4 LH LP – Sand

Catalogue number TASKA-C2CC31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Harness Pavlik Type

5 catalogue numbers from 51968/NA/MD, listed by Alimed, LLC, United States, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Glide

For the Motion Control ProWrist or Ottobock Myorotronic or Hand only configurations

Hand, External Limb Component, Powered

ThunderCell Battery

ThunderCell Battery, beige (device)

Hand, External Limb Component, Powered

Electrode

9 catalogue numbers from ELECTRODE CABLE, listed by Hugh Steeper Ltd, United Kingdom, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Battery System

13 catalogue numbers from 45MM KINISI SH WR HOUSING, listed by Hugh Steeper Ltd, United Kingdom, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 8 1/4 RH LP Black

Catalogue number TASKA-B1CB21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska Power System Kit, Gen1

Catalogue number TASKA-21AA11, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska CX Hand – 7 1/4 RH LP – Sand

Catalogue number TASKA-D1CC31-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 7 3/4 LH QWD Sand

Catalogue number TASKA-C2FC21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Taska HandGen2 Myoelectric Hand – 8 1/4 LH QWD White

Catalogue number TASKA-B2FA21-U1, listed by Taska Prosthetics, New Zealand, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Adam’s Hand

Adam's Hand - Left, Medium, White, Short Wrist + Short Wrist Lamination Kit 45

Hand, External Limb Component, Powered

MYO

51 catalogue numbers from BT KINISI 7 1/4 LH EQD WRIST, listed by Hugh Steeper Ltd, United Kingdom, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Hand, External Limb Component, Powered

Adam’s Skin

Adam's Skin - Glove for Adam's Hand (spare part) - Basic Glove - Color: A0 (advanced) - Side: Right - Size: Medium

Hand, External Limb Component, Powered

S-Charge

11 catalogue numbers from S-Charge Mounting Frame Kit, listed by Hugh Steeper Ltd, United Kingdom, under Hand, External Limb Component, Powered. 6 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer