Aircast
Insole FOR 01P-S (NEW Style)
6manufacturers in China registered for this device type
3catalogue 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 | 2023-07-05 |
| Record revised | 2024-03-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0146R | In distribution | |
| 0147R | In distribution | |
| 0145R | 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.