Ovation 400 OV-400
by Aretech, LLC
Ovation 400 OV-400 is a Class I device made by Aretech, LLC, listed in FDA GUDID since 24 Sep 2021 (UDI-DI 00850018836029), 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 | Number00850018836029 | Date24 Sep 2021 | StatusListed |
Official records
- AccessGUDID record 00850018836029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Ovation 400
- Generic name
- Gait rehabilitation frame, electric
- Model / reference
- OV-400
- Primary DI / UDI-DI
- 00850018836029
- FDA product code
- BXB
- GMDN term
- Gait rehabilitation frame, electric
- Device class
- Class I
- Regulation number
- 890.5380
- GUDID distribution status
- In Commercial Distribution
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