Dynamic Femur Fracture Brace

XXL DF2 Femur Fracture Brace, Right, Static Knee

Registry build 21.09.26
144manufacturers in China registered for this device type
12catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (46), Zhejiang (25), Jiangsu (20). 32 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IQI
Manufacturer City Province Registered as Device types
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Shanghai Leison Medical & Healthcare Products Co., Ltd. Shanghai Shanghai Contract manufacturer 32
Suzhou Sunmed Co., Ltd. Suzhou Jiangsu Contract manufacturer 28
Zhongshan Chukuang Textile Co., Ltd. Zhongshan Guangdong Contract manufacturer 26
Fortune Company Ltd. Huizhou Guangdong Contract manufacturer 23
Allmay Bodywear (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 21
Beijing Jinwei Kangda Medical Instrument Ltd. Langfang Hebei Contract manufacturer 21
Anji Hengfeng Sanitary Material Co., Ltd. Anji Zhejiang Contract manufacturer 20
Wellpower Sporting Goods Co., Ltd. Dong Guan Guangdong Contract manufacturer 18
Anhui Kangfu Industrial Foreign Trade Co., Ltd. Tianchang Anhui Contract manufacturer 18
Metacare Industrial Ltd Guangzhou Guangdong Contract manufacturer 17

Showing 12 of 144. All 144 manufacturers in China registered for Orthosis, Limb Brace

Record

Regulatory record for Dynamic Femur Fracture Brace
Listed by Orthopediatrics, Corp, United States
FDA product code IQI
Device type Orthosis, Limb Brace
Device class Class 1
Regulation 21 CFR 890.3475
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2023-06-25
Record revised 2023-11-15 (version 2)

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Distribution end date 2023-06-25

Catalogue Numbers

Catalogue numbers for Dynamic Femur Fracture Brace
Catalogue number Size Status
NS-DF2B-0102 In distribution
NS-DF2B-0003 In distribution
NS-DF2B-0103 In distribution
NS-DF2B-0002 In distribution
NS-DF2B-0004 In distribution
NS-DF2B-0104 In distribution
NS-DF2B-0005 Withdrawn
NS-DF2B-0101 Withdrawn
NS-DF2B-0006 Withdrawn
NS-DF2B-0001 Withdrawn
NS-DF2B-0106 Withdrawn
NS-DF2B-0105 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medi Medi Manufacturing Inc 984
DeRoyal Deroyal Industries, Inc. 295
Thrive Orthopedics Thrive Orthopedics 272
Formthotics Foot Science International, Ltd. 254
VQ Orthocare Vision Quest Industries, Inc. 156
Donjoy Performance DJO, LLC 78
Profit Pantymed S.A. 73
Procare DJO, LLC 63
PediHip Orthopediatrics, Corp 60
ComfyHealth Comfy Health Group Co., Ltd. 51
Push braces Nea International B.V. 48
Soft Stride Brownmed 44

Showing 12 of 664. All products under Orthosis, Limb 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