THERA Plus 64409535B
THERA Plus 64409535B is a Class I device made by Fourstar Group Inc., listed in FDA GUDID since 9 Jun 2026 (UDI-DI 00049696508377), 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 | Number00049696508377 | Date9 Jun 2026 | StatusListed |
Official records
- AccessGUDID record 00049696508377
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- THERA Plus
- Generic name
- Ankle binder, reusable
- Model / reference
- 64409535B
- Primary DI / UDI-DI
- 00049696508377
- FDA product code
- ITQ
- GMDN term
- Ankle binder, reusable
- Device class
- Class I
- Regulation number
- 890.3475
- GUDID distribution status
- In Commercial Distribution
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