DeRoyal
Pavlik Harness
9manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (2), Fujian (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| Dongguan Vigor Textile Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Hangzhou Weize IMP & EXP Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 34 |
| 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 |
| Zhejiang Rehan Medical Manufacturing Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 20 |
| Yangzhou Jindu Sporting Goods Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 7 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | IOZ |
| Device type | Splint, Abduction, Congenital Hip Dislocation |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3665 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-29 |
| Record revised | 2022-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8753-03 | In distribution | |
| 8753-01 | In distribution | |
| 8753-02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Span-America | Span-America Medical Systems, Inc. | 10 |
| Splint, Abduction, Congenital Hip Dislocation | Zimmer Orthopaedic Surgical Products | 4 |
| Trulife | Trulife, Inc. | 3 |
| Slimline™ Abduction Pillow | Innovative Medical Products, Inc. | 3 |
| Pediatric Abduction Pillow | Innovative Medical Products, Inc. | 2 |
| BMI | Blake Manufacturing, Inc. | 2 |
| Panacea | Blake Manufacturing, Inc. | 2 |
| Universal Abduction Pillow | Innovative Medical Products, Inc. | 2 |
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.