Henry Schein

Walker Pneumatic Ankle LG

Registry build 21.09.26
134manufacturers in China registered for this device type
30catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (34), Jiangsu (27), Zhejiang (20). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ITW
Manufacturer City Province Registered as Device types
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Shanghai Leison Medical & Healthcare Products Co., Ltd. Shanghai Shanghai Contract manufacturer 32
Zhongshan Chukuang Textile Co., Ltd. Zhongshan Guangdong Contract manufacturer 26
Fortune Company Ltd. Huizhou Guangdong Contract manufacturer 23
Lingxian Dongsheng Textile Co., Ltd. Dezhou Shandong Contract manufacturer 23
Allmay Bodywear (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 21
Beijing Jinwei Kangda Medical Instrument Ltd. Langfang Hebei Contract manufacturer 21
Wellpower Sporting Goods Co., Ltd. Dong Guan Guangdong Contract manufacturer 18
Anhui Kangfu Industrial Foreign Trade Co., Ltd. Tianchang Anhui Contract manufacturer 18
Jiangsu Reak Healthy Articles Co., Ltd. Yangzhong Jiangsu Contract manufacturer 18
Henan Huibo Medical Co., Ltd. Nanyang Henan Contract manufacturer 17
Metacare Industrial Ltd Guangzhou Guangdong Contract manufacturer 17

Showing 12 of 134. All 134 manufacturers in China registered for Joint, Ankle, External Brace

Record

Regulatory record for Henry Schein
Listed by Henry Schein, Inc., United States
FDA product code ITW
Device type Joint, Ankle, External Brace
Device class Class 1
Regulation 21 CFR 890.3475
Premarket notification Exempt
Record published 2019-10-25
Record revised 2022-08-30 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Supplied as a kit Yes
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Henry Schein
Catalogue number Size Status
5701027 In distribution
5701025 In distribution
5701032 In distribution
5701008 In distribution
5701014 In distribution
5701012 In distribution
5701016 In distribution
5701007 In distribution
5701018 In distribution
5701011 In distribution
5701031 In distribution
5701034 In distribution
5701020 In distribution
5701029 In distribution
5701023 In distribution
5701019 In distribution
5701006 In distribution
5701026 In distribution
5701010 In distribution
5701009 In distribution
5701033 In distribution
5701021 In distribution
5701030 In distribution
5701022 In distribution
5701028 In distribution
5701017 In distribution
5701013 In distribution
5701024 In distribution
5701035 In distribution
5701015 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DeRoyal Deroyal Industries, Inc. 480
Medi Medi Manufacturing Inc 209
Elite Orthopaedics Elite Orthopaedics, Inc. 134
CoreTech Vive Health LLC 118
Vive Vive Health LLC 76
Donjoy Performance DJO, LLC 60
ManaMed Manamed LLC 49
Profit Pantymed S.A. 43
Push braces Nea International B.V. 39
Tairuibosi Tianjin Tairuibosi Medical Appliance Co., Ltd. 36
TruCompress Vive Health LLC 35
BMI Blake Manufacturing, Inc. 32

Showing 12 of 414. All products under Joint, Ankle, External Brace

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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