NON Franchise

Baker Plantar Fasciitis Night Splint, Medium

Registry build 21.09.26
137manufacturers in China registered for this device type
61catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (35), Jiangsu (33), Zhejiang (18). 30 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ITQ
Manufacturer City Province Registered as Device types
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62
Shanghai Leison Medical & Healthcare Products Co., Ltd. Shanghai Shanghai Contract manufacturer 32
Xiamen Ortocare Sports Health Co., Ltd. Xiamen Free Trade Zone Fujian Contract manufacturer 32
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
Hengshui Xukang Medical Appliances Co., Ltd. Hengshui Hebei Contract manufacturer 21
Wenzhou Zuoyou Medical Technoloyg Co., Ltd. Wenzhou Zhejiang Contract manufacturer 21
Foshan Huafukang Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 19
Wellpower Sporting Goods Co., Ltd. Dong Guan Guangdong Contract manufacturer 18
Anhui Kangfu Industrial Foreign Trade Co., Ltd. Tianchang Anhui Contract manufacturer 18

Showing 12 of 137. All 137 manufacturers in China registered for Joint, Knee, External Brace

Record

Regulatory record for NON Franchise
Listed by DJO, LLC, United States
FDA product code ITQ
Device type Joint, Knee, External Brace
Device class Class 1
Regulation 21 CFR 890.3475
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-08-12
Record revised 2022-08-30 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only

Catalogue Numbers

Catalogue numbers for NON Franchise
Catalogue number Size Status
88-578000370534 In distribution
88-002000080604 In distribution
88-040000038387 In distribution
88-814008144802 In distribution
88-021000010057 In distribution
88-040000064224 In distribution
88-040000064122 In distribution
88-045000518713 In distribution
88-040000064132 In distribution
88-578000751015 In distribution
88-814000004021 In distribution
88-021000010383 In distribution
88-814008144803 In distribution
88-040000004813 In distribution
88-108000179497 In distribution
88-040000066756 In distribution
88-040000038388 In distribution
88-002000080706 In distribution
88-578000370513 In distribution
88-004000041214 In distribution
88-578000372162 In distribution
88-578000370530 In distribution
88-108000179498 In distribution
88-814000006295 In distribution
88-578000883065 In distribution
88-040000064123 In distribution
88-040000484823 In distribution
88-108000179494 In distribution
88-040000484833 In distribution
88-578000994303 In distribution
88-578000235243 In distribution
88-040000076401 In distribution
88-040000003813 In distribution
88-814000006293 In distribution
88-578000370511 In distribution
88-045000528712 In distribution
88-021000010381 In distribution
88-578000994301 In distribution
88-040000076407 In distribution
88-814000000019 In distribution
88-578000372163 In distribution
88-108000179496 In distribution
88-040000048494 In distribution
88-578000372183 In distribution
88-040000064234 In distribution
88-021000011053 In distribution
88-814000004020 In distribution
88-108000179495 In distribution
88-578000370512 In distribution
88-814000006292 In distribution
88-578000370501 In distribution
88-040000048493 In distribution
88-108000179499 In distribution
88-002000080704 In distribution
88-578000370520 In distribution
88-578000372071 In distribution
88-021000010393 In distribution
88-040000076406 In distribution
88-040000064133 In distribution
88-040000066751 In distribution
88-578000994302 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DeRoyal Deroyal Industries, Inc. 987
Medi Medi Manufacturing Inc 413
Vive Vive Health LLC 122
Donjoy Performance DJO, LLC 107
CoreTech Vive Health LLC 105
Gripper Hinged Knee Medical Specialties, Inc. 46
ManaMed Manamed LLC 46
Profit Pantymed S.A. 46
Copperfit Ideavillage Products Corp. 42
M-Brace Air Indaco SRL 42
Joint, Knee, External Brace Tetra Medical Supply Corp. 35
BMI Blake Manufacturing, Inc. 34

Showing 12 of 507. All products under Joint, Knee, 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