Konmed

It is a product can be used as medical purposes specified in Intended use and it is easy to wear and take off and with humanized design, which can be adjustable by customer desired with…

Registry build 21.09.26

It is a product can be used as medical purposes specified in Intended use and it is easy to wear and take off and with humanized design, which can be adjustable by customer desired with below feature: – The half-hard design at the bottom of the device and adjust and swing according to human walking habit, while the thin and soft design make it easy to wear and can help to recovery and satisfy patient’sdemand – The hollow designing on the heel part is good to wear – The cushion on the shin and shank can be disassembled, which is convenient to wash and good to maintain hygienic – With left and right design difference – The tiptoe part can be trimmed based on your size – The “8” shape straps is detachable

134manufacturers in China registered for this device type
1catalogue number

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 Konmed
Listed by Shenzhen Konmed Technology Co., Ltd., China
FDA product code ITW
Device type Joint, Ankle, External Brace
Device class Class 1
Regulation 21 CFR 890.3475
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2018-01-24
Record revised 2021-02-05 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Konmed
Catalogue number Size Status
KM-F-58 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