Unit, Wrist, External Limb Component, Mechanical

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are concentrated in Guangdong, Hebei and Zhejiang: 4 hold an FDA registration.

Dongguan Supercare Medical Products Co., Ltd. Guangdong, contract manufacturer
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangdong, contract manufacturer
Hengshui Gangsheng Medical Instruments Co., Ltd. Hebei, contract manufacturer
Huzhou Universal Glove Company Limited Zhejiang

What Is FDA Product Code ISZ?

Unit, Wrist, External Limb Component, Mechanical is FDA product code ISZ, 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.

Unit, Wrist, External Limb Component, Mechanical

MC Seal Ring Kit, Small, Sand

Catalogue number 193-20-029, listed by Taska Prosthetics, New Zealand, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Ball Module STD Without Spacer

Catalogue number 0103(1/2)000, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Taska Seal Ring Kit, 45mm, Sand

Catalogue number 193-20-028, listed by Taska Prosthetics, New Zealand, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Taska Seal Ring Kit, 45mm, Black

Catalogue number 193-20-025, listed by Taska Prosthetics, New Zealand, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Ring EXP

Catalogue number 0101(3/4)000, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Hold Lock O-2 Module

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Taska Lamination Collar Kit (6-Band), 50mm, Sand

Catalogue number TASKA-13AC01, listed by Taska Prosthetics, New Zealand, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Hold Module STD Without Spacer

Catalogue number 0109(1/2)000, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Bike Module STD Without Spacer

Catalogue number 0102(1/2)000, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Ball Module SML With Spacer

Catalogue number 0103(3/4)xxx, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Low Profile Lamination Kit, CX, 45mm

Catalogue number 193-20-011, listed by Taska Prosthetics, New Zealand, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Twin Module LRG Without Spacer

Catalogue number 0105(3/4)000, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Pinch Module STD Without Spacer

Catalogue number 0108(1/2)000, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

MC Seal Ring Kit, Medium/Large, Black

Catalogue number 195-20-004, listed by Taska Prosthetics, New Zealand, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

MC Seal Ring Kit, Medium/Large, Sand

Catalogue number 195-20-004-SN, listed by Taska Prosthetics, New Zealand, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

MC Seal Ring Kit, Small, Black

Catalogue number 193-20-010, listed by Taska Prosthetics, New Zealand, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Taska Lamination Collar Kit (6-Band), 45mm, Sand

Catalogue number TASKA-12BC01, listed by Taska Prosthetics, New Zealand, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Ball Module SML Without Spacer

Catalogue number 0103(3/4)000, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Twin Module STD Without Spacer

Catalogue number 0105(1/2)000, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Hold Module Spacer

Catalogue number 0109(1/2)xxx, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Taska Lamination Collar Kit (6-Band), 50mm, Black

Catalogue number TASKA-13AB01, listed by Taska Prosthetics, New Zealand, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Taska Seal Ring Kit, 50mm, Sand

Catalogue number 195-20-003-SN, listed by Taska Prosthetics, New Zealand, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Swim Module STD Without Spacer

Catalogue number 0104(1/2)000, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Medi

***disc*manumed Active Wrist Left Sand X

Unit, Wrist, External Limb Component, Mechanical

Explorer Swim Module SML Without Spacer

Catalogue number 0104(3/4)000, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Low Profile Lamination Kit, CX, 50mm

Catalogue number TASKA-13CD01, listed by Taska Prosthetics, New Zealand, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Twin Module STD With Spacer

Catalogue number 0105(1/2)xxx, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Ring STD

Catalogue number 0107(1/2)000, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Ball Module STD With Spacer

Catalogue number 0103(1/2)xxx, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Bike Module STD With Spacer

Catalogue number 0102(1/2)xxx, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Hold Lock Module

Catalogue number v1.0, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Taska Seal Ring Kit, 50mm, Black

Catalogue number 195-20-003, listed by Taska Prosthetics, New Zealand, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Pinch Module Spacer

Catalogue number 0108(1/2)xxx, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Wrist

37 catalogue numbers from Hand Plate North American 0.5in 40mm, listed by Hugh Steeper Ltd, United Kingdom, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Explorer Twin Module LRG With Spacer

Catalogue number 0105(3/4)xxx, listed by macu4 GmbH, Germany, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Taska Lamination Collar Kit (6-Band), 45mm, Black

Catalogue number TASKA-12BB01, listed by Taska Prosthetics, New Zealand, under Unit, Wrist, External Limb Component, Mechanical. 4 manufacturers in China are registered for this product code.

Unit, Wrist, External Limb Component, Mechanical

Who Makes This Device Type in China?

What Is FDA Product Code ISZ?

How Does It Reach the US Market?

Where China Actually Supplies