McKie Thumb Splint Pediatric

McKie Thumb Splint - Pediatric Size 1 - Right Hand - Royal Blue Color

Registry build 21.09.26
144manufacturers in China registered for this device type
60catalogue 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 McKie Thumb Splint Pediatric
Listed by Mckie Splints, LLC, United States
FDA product code ILH
Device type Splint, Hand, And Components
Device class Class 1
Regulation 21 CFR 890.3475
Establishment Manufacturer
Premarket notification Exempt
Record published 2023-06-26

Specifications

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

Catalogue Numbers

Catalogue numbers for McKie Thumb Splint Pediatric
Catalogue number Size Status
P4-R Tan In distribution
P1-L Tan In distribution
P4-R Pink In distribution
P5-R Tan In distribution
P1-R Red In distribution
P3-L Red In distribution
P2-L Royal In distribution
P5-L Pink In distribution
P4-L Black In distribution
P5-R Red In distribution
P2-L Black In distribution
P4-R Black In distribution
P2-R Pink In distribution
P6-R Black In distribution
P6-L Royal In distribution
P2-L Red In distribution
P3-R Red In distribution
P3-L Black In distribution
P6-R Pink In distribution
P5-L Red In distribution
P3-R Black In distribution
P1-R Pink In distribution
P5-L Tan In distribution
P2-R Tan In distribution
P4-L Pink In distribution
P1-L Black In distribution
P4-R Red In distribution
P6-R Tan In distribution
P2-L Tan In distribution
P1-R Royal In distribution
P2-R Black In distribution
P4-L Tan In distribution
P3-R Pink In distribution
P1-R Tan In distribution
P1-L Royal In distribution
P4-L Red In distribution
P5-L Royal In distribution
P6-R Royal In distribution
P2-R Royal In distribution
P1-L Red In distribution
P5-R Pink In distribution
P6-L Black In distribution
P6-L Red In distribution
P4-R Royal In distribution
P1-L Pink In distribution
P3-R Royal In distribution
P5-R Black In distribution
P3-L Tan In distribution
P3-L Pink In distribution
P2-L Pink In distribution
P3-R Tan In distribution
P6-R Red In distribution
P1-R Black In distribution
P6-L Pink In distribution
P5-L Black In distribution
P4-L Royal In distribution
P6-L Tan In distribution
P5-R Royal In distribution
P2-R Red In distribution
P3-L Royal 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
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