Component, External, Limb, Ankle/Foot

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Zhejiang, Anhui and Fujian, and 4 other provinces: 14 hold an FDA registration. 1 is a contract manufacturer.

AID United International Co., Limited Shanghai
Baoji Shengtaike Industry & Trade Co., Ltd. Shanxi, contract manufacturer
Fortune Company Ltd. Guangdong, contract manufacturer
Fujian Guozi Rehabilitation Medical Co., Ltd. Fujian
Hefei Mlush Sanitary Products Co., Ltd. Anhui
Huae Trade Technology Co., Ltd. Beijing, contract manufacturer
Kaipeng Medical Tech Development Co., Ltd. Zhejiang
Medex Medical Supplies Ltd. Guangdong, contract manufacturer
Ningbo Castle Medical Import & Export Co., Ltd. Zhejiang, contract manufacturer
Ningbo Ningyuan Import & Export Co., Ltd. Zhejiang, contract manufacturer
Orthotech Rehabilitation Co., Ltd. Fujian
Planet (Anhui) International Co., Ltd. Anhui
T&L (Jiaxing) Co., Ltd. Zhejiang
TF NEW Material SCI AND TEC Co., Ltd. Anhui

How Is ISH Classified?

Component, External, Limb, Ankle/Foot is FDA product code ISH, 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 Do the Recalls Say?

The FDA has recorded 13 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (2), Device Design (1) and Mixed-up of materials/components (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Component, External, Limb, Ankle/Foot

Tehlin

Feather Carbon Foot W. Ankle Joint (26R)

Component, External, Limb, Ankle/Foot

Goralign PSA 2

Goralign PSA 2, where “PSA” stands for “Plus Shock Absorber”, is the next generation of Impulse Technology's prosthetic ankle that self-adapts to uneven terrain and enhances patient comfort…

Component, External, Limb, Ankle/Foot

iVT Tempo

Tempo IVT Foot, Left, Brown, Endo IP, 21cm, Category 1

Component, External, Limb, Ankle/Foot

Xtend Connect Shape A200

Quick connector

Component, External, Limb, Ankle/Foot

Xtend Connect A100

11 catalogue numbers from A100-QP-150-O, listed by C Lindhextend AB, under Component, External, Limb, Ankle/Foot. 14 manufacturers in China are registered for this product code.

Component, External, Limb, Ankle/Foot

Sidekicks

Sidekicks Foot Assembly, Single, Category 1

Component, External, Limb, Ankle/Foot

Sach Foot for Children

SACH Foot for Children with Split Toe, size: 20 cm, side: right, weight: 210 g, height: 63 mm, thread M8, max. body weight: 45 kg

Component, External, Limb, Ankle/Foot

Lunaris® Essential

Articulated prosthetic ankle-foot component with spring category C5. The device is intended for the replacement of the ankle and foot function as a component of a prosthesis that…

Component, External, Limb, Ankle/Foot

Steady Step

Steady Step® Toehold®

Component, External, Limb, Ankle/Foot

Breeze

Breeze Foot, Right, Caucasian, Endo IP, 22cm, Category 3

Component, External, Limb, Ankle/Foot

Goralign PSA

Goralign PSA is a self-adaptive prosthetic ankle component. It is integrated with and in between a prosthetic foot and a pylon or socket. Goralign PSA 2, where “PSA” stands for “Plus Shock…

Component, External, Limb, Ankle/Foot

Celsus

Celsus Foot, Right, Caucasian, Endo IP, 24cm, Category 1

Component, External, Limb, Ankle/Foot

Odyssey K2

Odyssey K2 Foot, Right, Caucasian, Endo IP, 23cm, Category 1

Component, External, Limb, Ankle/Foot

Voyager

Voyager Foot, Right, Jet Black, Endo IP, 27cm, Category 3

Component, External, Limb, Ankle/Foot

Biostep LP

BioStep LP, Size 26, Right, Rate H, Dark

Component, External, Limb, Ankle/Foot

Orbit

Orbit Foot, Right, Jet Black, Endo IP, 29cm, Category 6

Component, External, Limb, Ankle/Foot

Xtend Foot H100

Prosthetic Foot

Component, External, Limb, Ankle/Foot

Biostep PRO

BioStep PRO, Size 29, Right, Rate 85, Dark

Component, External, Limb, Ankle/Foot

iVT Celsus

Celsus IVT Foot, Right, Caucasian, Endo IP, 30cm, Category 3

Component, External, Limb, Ankle/Foot

Hoizon HD

Horizon HD Foot, Right, Jet Black, Endo IP, 22cm, Category 3

Component, External, Limb, Ankle/Foot

Biostep CL

BioStep CL, Size 23, Right, Rate 42, Dark

Component, External, Limb, Ankle/Foot

Accent

Accent Foot, Right, Caucasian, DP 4HPA, Lateral Btn, 27cm, Narrow, Category 3

Component, External, Limb, Ankle/Foot

Xtend Foot Fri H100

Prosthetic Foot

Component, External, Limb, Ankle/Foot

Biostep XT

BioStep XT, Size 22, Right, Rate 21, Dark

Component, External, Limb, Ankle/Foot

Tempo

Tempo Foot, Right, Caucasian, Endo IP, 23cm, Category 2

Component, External, Limb, Ankle/Foot

Scout

Scout Foot, Right, Caucasian, Midnight Black Housing, 17cm, Category 3

Component, External, Limb, Ankle/Foot

Odyssey Iq

Odyssey iQ Foot, Right, Jet Black, Endo IP, 30cm, Category 2

Component, External, Limb, Ankle/Foot

Odyssey K3

Odyssey K3 Foot, Right, Jet Black, Endo IP, 30cm, Category 3

Component, External, Limb, Ankle/Foot

Trulife

Trulife Zenith LP Foot 27CM Right CAT 3 DK BRN

Component, External, Limb, Ankle/Foot

Terrain Iw

Terrain iW Foot, Right, Caucasian, Endo IP, 21cm, Category 1

Component, External, Limb, Ankle/Foot

Terrain

Terrain Foot, Right, Caucasian, Endo IP, 30cm, Category 4

Component, External, Limb, Ankle/Foot

Onyx

Onyx Foot, Right, Jet Black, DP 4HPA, 30cm, Narrow, Category 42

Component, External, Limb, Ankle/Foot

Velocity

Velocity Foot, Right, Jet Black, Midnight Black Housing, Endo IP, 30cm, Narrow, Category 2

Component, External, Limb, Ankle/Foot

Biostep EVO

BioStep EVO, Size 29, Right, Rate 42, Dark

Component, External, Limb, Ankle/Foot

Aviator

Aviator Foot, Right, Jet Black, Endo IP, 24cm, Category 1

Component, External, Limb, Ankle/Foot

Tribute

Tribute Foot, Right, Caucasian, Endo IP, Sandal Toe, 24cm, Category 2

Component, External, Limb, Ankle/Foot

Soleus

Soleus Foot, Right, Caucasian, Midnight Black Housing, 21cm, Narrow, Category 34

Component, External, Limb, Ankle/Foot

Venture

Venture Foot, Right, Jet Black, Endo IP, 28cm, Narrow, Category 2

Component, External, Limb, Ankle/Foot

TruStep

Trustep Foot, Right, Jet Black, Exo ALX, 29cm, Narrow, Category 7

Component, External, Limb, Ankle/Foot

Truper

Truper Foot, Right, Caucasian, Endo IP, 16cm, Category 1

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