Primo GB60QRNB
Primo GB60QRNB is a Class I device made by Asp Global, LLC, listed in FDA GUDID since 8 Apr 2022 (UDI-DI 00840216113992), 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 | Number00840216113992 | Date8 Apr 2022 | StatusListed |
Official records
- AccessGUDID record 00840216113992
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Primo
- Generic name
- Gait rehabilitation system harness
- Model / reference
- GB60QRNB
- Primary DI / UDI-DI
- 00840216113992
- FDA product code
- IKX
- GMDN term
- Gait rehabilitation system harness
- Device class
- Class I
- Regulation number
- 890.5050
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code IKX (Aid, Transfer).
- BOARD, TRANSFER, FENDER by Fred Sammons, Inc.
- SLIDING BOARD by Fred Sammons, Inc.
- DISC-O-AID by M. Dahm International Aps
- SHOWER STOOL W/HANDLES by Orthion Corp.
- BATHTUB TRANSFER BENCH by Guardian Products Co., Inc.
- TRICYCLES by Mednet, Inc.
- Henry Schein 9006047 by HENRY SCHEIN, INC.
- TRANSFER BENCH by Maddak, Inc.
- TAYLOR PATIENT TRANSFER BOARD by Taylor Medical Equipment
- BATH TUB SEAT & BATH BOARD by Orthion Corp.