BMI

Resting Hand with Thumb Abductor and Keyhole Strap orthosis. Size: Regular, Side: Right

Registry build 21.09.26
144manufacturers in China registered for this device type
87catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (36), Zhejiang (32), Jiangsu (30). 30 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ILH
Manufacturer City Province Registered as Device types
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Hengshui Gangsheng Medical Instruments Co., Ltd. Hengshui Hebei Contract manufacturer 36
Shanghai Leison Medical & Healthcare Products Co., Ltd. Shanghai Shanghai Contract manufacturer 32
Zhejiang Anji Huabu Industrial Co., Ltd. Huzhou Zhejiang Contract manufacturer 32
Planet (Anhui) Medical Products Co., Ltd. Chuzhou Anhui Contract manufacturer 30
Zhongshan Chukuang Textile Co., Ltd. Zhongshan Guangdong Contract manufacturer 26
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
Hengshui Xukang Medical Appliances Co., Ltd. Hengshui 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

Showing 12 of 144. All 144 manufacturers in China registered for Splint, Hand, And Components

Record

Regulatory record for BMI
Listed by Blake Manufacturing, Inc.
FDA product code ILH
Device type Splint, Hand, And Components
Device class Class 1
Regulation 21 CFR 890.3475
Premarket notification Exempt
Record published 2022-08-17

Specifications

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

Catalogue Numbers

Catalogue numbers for BMI
Catalogue number Size Status
HTA-RL In distribution
HPR-PR In distribution
MSC-FM-P In distribution
HTA-KH-PL In distribution
HSF-LR In distribution
HTA-KH-RL In distribution
HRX-KH-PR In distribution
HPR-LR In distribution
HPR-RR In distribution
HRE-KH-PL In distribution
HGR-LL In distribution
HRFM-LL In distribution
HSE-UL In distribution
HSG-PR In distribution
HRE-LL In distribution
HRFM-RL In distribution
HSF-RR In distribution
HGR-LR In distribution
HRE-LR In distribution
HRX-RR In distribution
HRE-KH-PR In distribution
MSC-PG-R In distribution
HPA-RR In distribution
HPR-PL In distribution
HRE-KH-LR In distribution
MSC-PG-L In distribution
HRFM-LR In distribution
HPR-RL In distribution
HSF-LL In distribution
HGR-RR In distribution
HTA-KH-LR In distribution
HRX-KH-PL In distribution
HRX-KH-RL In distribution
HSG-LL In distribution
HRFM-PR In distribution
MSC-FM-R In distribution
HCG-LL In distribution
HRX-PR In distribution
HPA-PL In distribution
HSA-U In distribution
HSG-RR In distribution
HTA-KH-LL In distribution
HRX-RL In distribution
HPR-LL In distribution
HRE-PR In distribution
HSG-LR In distribution
HTA-PR In distribution
HPA-LL In distribution
HRE-RR In distribution
HRX-KH-RR In distribution
HSF-PR In distribution
HNE-UR In distribution
HRE-KH-RR In distribution
HSO-U In distribution
HTA-RR In distribution
HTA-LR In distribution
HRFM-PL In distribution
HGR-PR In distribution
HNE-UL In distribution
HTA-KH-PR In distribution
HGR-PL In distribution
HRX-KH-LL In distribution
HRX-PL In distribution
HCG-RR In distribution
HSG-PL In distribution
HRE-RL In distribution
HRX-LR In distribution
HSO-FIRM-U In distribution
HTA-LL In distribution
HSF-RL In distribution
HRE-PL In distribution
HCG-LR In distribution
HRE-KH-RL In distribution
HSF-PL In distribution
HPA-RL In distribution
HPA-PR In distribution
HRE-KH-LL In distribution
HRX-KH-LR In distribution
HTA-PL In distribution
HGR-RL In distribution
HSE-UR In distribution
HCG-RL In distribution
HTA-KH-RR In distribution
HRFM-RR In distribution
HPA-LR In distribution
HRX-LL In distribution
HSG-RL In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DeRoyal Deroyal Industries, Inc. 1,511
Splint, Hand, And Components Tetra Medical Supply Corp. 111
Plastalume Brownmed 102
Panacea Blake Manufacturing, Inc. 78
Klarity Medical Klarity Medical Products, LLC 65
Vive Vive Health LLC 61
McKie Thumb Splint Pediatric Mckie Splints, LLC 60
Performance Health ASP Global, LLC 59
McKie Thumb Splint Adult Mckie Splints, LLC 47
Wrist Lacer Medical Specialties, Inc. 38
Elite Orthopaedics Elite Orthopaedics, Inc. 34
Ryno Lacer Wrist and Thumb Support Medical Specialties, Inc. 31

Showing 12 of 254. All products under Splint, Hand, And Components

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