Elite Orthopaedics

10" Memory Foam Wrist Splint, X-Large Right

Registry build 21.09.26
144manufacturers in China registered for this device type
34catalogue 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 Elite Orthopaedics
Listed by Elite Orthopaedics, Inc., United States
FDA product code ILH
Device type Splint, Hand, And Components
Device class Class 1
Regulation 21 CFR 890.3475
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2023-08-17
Record revised 2026-02-09 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes

Catalogue Numbers

Catalogue numbers for Elite Orthopaedics
Catalogue number Size Status
32100-R In distribution
30064-L In distribution
30164-L In distribution
30165-R In distribution
31063-L In distribution
32000-R In distribution
30064-R In distribution
31065-R In distribution
32000-L In distribution
30062-L In distribution
30062-R In distribution
30161-R In distribution
31061-R In distribution
30162-L In distribution
30164-R In distribution
30061-L In distribution
30065-L In distribution
31062-L In distribution
30162-R In distribution
30061-R In distribution
30063-R In distribution
31064-L In distribution
31063-R In distribution
30161-L In distribution
30165-L In distribution
30163-L In distribution
31062-R In distribution
31065-L In distribution
30063-L In distribution
31064-R In distribution
32100-L In distribution
30065-R In distribution
30163-R In distribution
31061-L 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
BMI Blake Manufacturing, Inc. 87
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
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