Donjoy
Playmaker II, X-ROM, XXL, Black
6manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Fujian (2), Taiwan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GuoLong (Shenzhen) High Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Zhangzhou Recaring Medical Instrument Co., Ltd. | Zhangzhou | Fujian | Manufacturer | 24 |
| Abletech Orthopedics Corporation | New Taipei | Taiwan | Contract manufacturer | 21 |
| Zhangpu Ortholife Rehabilitation Co., Ltd. | Zhangzhou | Fujian | Manufacturer | 21 |
| Guangdong Hexin Technology Weaving Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 17 |
| Dongguan Sava Sporting Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
Record
| Listed by | DJO, LLC, United States |
|---|---|
| FDA product code | ITC |
| Device type | Stirrup, External Brace Component |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3410 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-10 |
| Record revised | 2026-02-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11-1585-4 | In distribution | |
| 11-0021-6 | In distribution | |
| 11-1585-2 | In distribution | |
| 11-0309-0-00000 | In distribution | |
| 11-1585-5 | In distribution | |
| 11-1585-3 | In distribution | |
| 11-1585-6 | In distribution |
Same Product Code
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.