Trulife
PED HIP Abduct Orthosis SM
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 | Trulife, Inc., United States |
|---|---|
| FDA product code | IOZ |
| Device type | Splint, Abduction, Congenital Hip Dislocation |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3665 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-31 |
| Record revised | 2026-01-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2026-01-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 015COH1 | Withdrawn | |
| 015COH3 | Withdrawn | |
| 015COH2 | Withdrawn |
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 |
| DeRoyal | Deroyal Industries, 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.