Mecron Elbow Splint Pediatric

XXS Blue-Orange

Registry build 21.09.26
72manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (18), Zhejiang (13), Jiangsu (13). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IOY
Manufacturer City Province Registered as Device types
Hengshui Gangsheng Medical Instruments Co., Ltd. Hengshui Hebei Contract manufacturer 36
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
Allmay Bodywear (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 21
Beijing Jinwei Kangda Medical Instrument Ltd. Langfang Hebei Contract manufacturer 21
Anhui Kangfu Industrial Foreign Trade Co., Ltd. Tianchang Anhui Contract manufacturer 18
Yangzhou Juli Sports Articles Co., Ltd. Yangzhou Jiangsu Contract manufacturer 16
Yangzhou Feiyali Sporting Goods Co., Ltd. Yangzhou Jiangsu Contract manufacturer 15
Hengshui Tianjian Medical Supplies Co., Ltd. Shenzhou Hebei Contract manufacturer 14
Dongguan Tutamen Metalwork Co., Ltd. Dongguan Guangdong Contract manufacturer 12
Yangzhou Haiwang Toothbrush Factory Yangzhou Jiangsu Contract manufacturer 12

Showing 12 of 72. All 72 manufacturers in China registered for Support, Arm

Record

Regulatory record for Mecron Elbow Splint Pediatric
Listed by Darco (Europe) GmbH, Germany
FDA product code IOY
Device type Support, Arm
Device class Class 1
Regulation 21 CFR 890.3475
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2023-02-08
Record revised 2025-04-10 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, manufacturing date
Packaging Case of 36, box of 12

Catalogue Numbers

Catalogue numbers for Mecron Elbow Splint Pediatric
Catalogue number Size Status
OS030X01 In distribution
OS030001 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Juzo Soft Julius Zorn, Inc. 432
Juzo Dynamic Julius Zorn, Inc. 312
Juzo Soft Seamless Julius Zorn, Inc. 272
Juzo Custom Compression Garments Julius Zorn, Inc. 94
Juzo Expert Julius Zorn, Inc. 63
Juzo Ortho Supports Julius Zorn, Inc. 36
Juzo Suspension Sleeve Julius Zorn, Inc. 30
Juzo Basic Seamless Julius Zorn, Inc. 24
Rhino MD Orthopaedics 19
Medi Medi Manufacturing Inc 11
Walgreens Walgreen Co. 11
Elbow Sleeve Neoprene Alimed, LLC 4

Showing 12 of 52. All products under Support, Arm

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