CoreTech

1906 Motion Ankle Brace (Black) (Right) Medium

Registry build 21.09.26
134manufacturers in China registered for this device type
118catalogue 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 CoreTech
Listed by Vive Health LLC, United States
FDA product code ITW
Device type Joint, Ankle, External Brace
Device class Class 1
Regulation 21 CFR 890.3475
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-08-15
Record revised 2023-02-09 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number
Packaging Case of 6, case of 10, case of 40, case of 20, case of 12, case of 8
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for CoreTech
Catalogue number Size Status
SUP2028BLKS In distribution
SUP2044BLKRXS In distribution
SUP2029BLKS In distribution
SUP3137BLKL In distribution
SUP2029BLKL In distribution
SUP3092BLKTM In distribution
SUP3120BLKRXL In distribution
SUP3135BLKL In distribution
SUP3092BLKTL In distribution
SUP3091BLKSM In distribution
SUP3092BLKSXS In distribution
SUP2035BLKM In distribution
SUP3091BLKSXS In distribution
SUP3120BLKRL In distribution
SUP2044BLKRS In distribution
SUP3091BLKTXS In distribution
SUP2033BLKM In distribution
SUP3053BLKLM In distribution
SUP2033BLKS In distribution
SUP3138BLKXL In distribution
SUP3092BLKSL In distribution
SUP2032BLKS In distribution
SUP2033BLKXS In distribution
SUP3120BLKRS In distribution
SUP3073BLKXL In distribution
SUP2032BLKL In distribution
SUP2028BLKXL In distribution
SUP3053BLKRM In distribution
SUP3135BLKM In distribution
SUP3092BLKSM In distribution
SUP3135BLKXL In distribution
SUP2034BLKM In distribution
SUP3120BLKLS In distribution
SUP3037BLKXS In distribution
SUP3091BLKSL In distribution
SUP2029BLKXS In distribution
SUP3120BLKLL In distribution
SUP2036SM In distribution
SUP2034BLKS In distribution
SUP2028BLKM In distribution
SUP2032BLKXL In distribution
SUP2044BLKRL In distribution
SUP3138BLKM In distribution
SUP3091BLKTL In distribution
SUP3037BLKM In distribution
SUP2044BLKLL In distribution
SUP3053BLKLS In distribution
SUP3036BLKS In distribution
SUP3120BLKRM In distribution
SUP3091BLKTXL In distribution
SUP3036BLKM In distribution
SUP3073BLKXS In distribution
SUP3136BLKXL In distribution
SUP3091BLKSXL In distribution
SUP2028BLKXS In distribution
SUP2070BLKM In distribution
SUP2037SM In distribution
SUP3053BLKRL In distribution
SUP2070BLKS In distribution
SUP3136BLKM In distribution
SUP3136BLKXS In distribution
SUP2032BLKM In distribution
SUP3092BLKTXS In distribution
SUP3120BLKLM In distribution
SUP2035BLKXS In distribution
SUP2033BLKL In distribution
SUP3137BLKXS In distribution
SUP3138BLKXS In distribution
SUP3037BLKXL In distribution
SUP2034BLKXL In distribution
SUP2036LXL In distribution
SUP3136BLKS In distribution
SUP3137BLKXL In distribution
SUP3091BLKSS In distribution
SUP2032BLKXS In distribution
SUP3135BLKS In distribution
SUP2033BLKXL In distribution
SUP2034BLKL In distribution
SUP3037BLKS In distribution
SUP2029BLKM In distribution
SUP3037BLKL In distribution
SUP2044BLKLS In distribution
SUP3091BLKTS In distribution
SUP3120BLKLXL In distribution
SUP3092BLKTXL In distribution
SUP2044BLKLXS In distribution
SUP3091BLKTM In distribution
SUP3036BLKL In distribution
SUP2044BLKLM In distribution
SUP3124BLK In distribution
SUP2035BLKXL In distribution
SUP2035BLKS In distribution
SUP2029BLKXL In distribution
SUP3138BLKL In distribution
SUP3138BLKS In distribution
SUP3120BLKRXS In distribution
SUP3073BLKL In distribution
SUP3053BLKRS In distribution
SUP3170 In distribution
SUP3137BLKS In distribution
SUP3136BLKL In distribution
SUP3120BLKLXS In distribution
SUP2035BLKL In distribution
SUP3092BLKSS In distribution
SUP2044BLKRM In distribution
SUP3053BLKLL In distribution
SUP3092BLKTS In distribution
SUP3137BLKM In distribution
SUP2028BLKL In distribution
SUP3073BLKM In distribution
SUP3073BLKS In distribution
SUP2037LXL In distribution
SUP3135BLKXS In distribution
SUP3036BLKXL In distribution
SUP3036BLKXS In distribution
SUP3092BLKSXL In distribution
SUP2070BLKL In distribution
SUP2034BLKXS 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
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
Henry Schein Henry Schein, Inc. 30

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