Primo GBARQM36PK
Primo GBARQM36PK is a Class I device made by Asp Global, LLC, listed in FDA GUDID since 8 Apr 2022 (UDI-DI 00840216107052), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840216107052 | Date8 Apr 2022 | StatusListed |
Official records
- AccessGUDID record 00840216107052
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Primo
- Generic name
- Gait rehabilitation system harness
- Model / reference
- GBARQM36PK
- Primary DI / UDI-DI
- 00840216107052
- FDA product code
- IKX
- GMDN term
- Gait rehabilitation system harness
- Device class
- Class I
- Regulation number
- 890.5050
- GUDID distribution status
- In Commercial Distribution
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