DeRoyal M5168
DeRoyal M5168 is a Class I device made by Deroyal Industries, Inc., listed in FDA GUDID since 3 Aug 2021 (UDI-DI 00749756613637), 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 | Number00749756613637 | Date3 Aug 2021 | StatusListed |
Official records
- AccessGUDID record 00749756613637
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- DeRoyal
- Generic name
- Gait rehabilitation system harness
- Model / Ref / Catalog
- M5168
- Primary DI / UDI-DI
- 00749756613637
- 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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