Ondamed 001-00-0101
by Ondamed Inc.
Ondamed 001-00-0101 is a Class II device made by Ondamed Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00852318007000), registry data as of 22 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 | Number00852318007000 | Date24 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00852318007000
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Ondamed
- Generic name
- Biofeedback system
- Model / Ref / Catalog
- 001-00-0101
- Primary DI / UDI-DI
- 00852318007000
- FDA product code
- HCC
- GMDN term
- Biofeedback system
- Device class
- Class II
- Regulation number
- 882.5050
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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