BMI

Knee Corrective Orthosis with Air Bladder. Size Extra-Large/Right

Registry build 21.09.26
137manufacturers in China registered for this device type
34catalogue 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 BMI
Listed by Blake Manufacturing, Inc.
FDA product code ITQ
Device type Joint, Knee, External Brace
Device class Class 1
Regulation 21 CFR 890.3475
Premarket notification Exempt
Record published 2021-12-10
Record revised 2022-08-30 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number
Distribution end date 2021-12-10

Catalogue Numbers

Catalogue numbers for BMI
Catalogue number Size Status
KCO-LL In distribution
KCO-SL In distribution
KCA-PR In distribution
KCA-ML In distribution
KCA-SR In distribution
KCA-XXL In distribution
KCO-PR In distribution
KCA-SL In distribution
KCO-XR In distribution
KCO-LR In distribution
KNE-M In distribution
KCA-XXR In distribution
KCO-PL In distribution
KCA-PL In distribution
KNE-S In distribution
KCA-XL In distribution
KNE-X In distribution
KCK-UR In distribution
KCA-MR In distribution
KCO-XL In distribution
KCO-MR In distribution
KCK-SR In distribution
KCO-SR In distribution
KNE-L In distribution
KCK-UL In distribution
MSC-AP In distribution
KCA-XR In distribution
KCO-XXL In distribution
KCA-LL In distribution
MSC-AP-DS In distribution
KCO-XXR In distribution
KCA-LR In distribution
KCO-ML In distribution
KCK-SL Withdrawn

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
NON Franchise DJO, LLC 61
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

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