Mitchell Ponseti® Bracing System
Catalogue number HDWEKIT, listed by MD Orthopaedics, United States, under Splint, Denis Brown. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
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.
| 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
| 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 | 2026-03-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HDWEKIT | In distribution |
Same 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® Move Bar | MD Orthopaedics | 6 |
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.