Mitchell Ponseti® Move Bar

Mitchell Ponseti® Move Bar Short 10°

Registry build 21.09.26
3manufacturers in China registered for this device type
6catalogue numbers in this listing

Who Else Makes It

Concentrated in Hebei (1), Guangdong (1), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ITN
Manufacturer City Province Registered as Device types
Beijing Jinwei Kangda Medical Instrument Ltd. Langfang Hebei Contract manufacturer 21
Dongguan Vigor Textile Co., Ltd. Dongguan Guangdong Contract manufacturer 11
Putian Lake Sports Goods Co., Ltd. Putian Fujian Manufacturer 1

Record

Regulatory record for Mitchell Ponseti® Move Bar
Listed by MD Orthopaedics, United States
FDA product code ITN
Device type Splint, Denis Brown
Device class Class 1
Regulation 21 CFR 890.3675
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2023-03-22

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 Mitchell Ponseti® Move Bar
Catalogue number Size Status
MP Move Short 10° In distribution
MP Move Long 15° In distribution
MP Move Short 15° In distribution
MP Move Long 10° In distribution
MP Move Medium 15° In distribution
MP Move Medium 10° In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Dobbs D-Bar Enterprises, LLC 14
Ponseti® Plus Abduction Bar MD Orthopaedics 13
Ponseti® Lite MD Orthopaedics 12
MD Orthopaedics MD Orthopaedics 6
Mitchell Ponseti® Bracing System MD Orthopaedics 1

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