FREDDO 120 v
FREDDO 120 v is a Class II device made by Fabinject LLC, cleared under FDA 510(k) K242132 on 18 Oct 2024 and listed in FDA GUDID since 28 Oct 2024 (UDI-DI 00850064466027), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850064466027 | Date28 Oct 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK242132 | Date18 Oct 2024 | StatusActive |
Official records
- AccessGUDID record 00850064466027
- FDA 510(k) database K242132
Across registries
- FDA 510(k) K242132 decided 18 Oct 2024 Active
- FDA GUDID UDI-DI 00850064466027 listed 28 Oct 2024 Listed
Timeline
- Cleared FDA 510(k) K242132
- Listed FDA GUDID 00850064466027
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Freddo
- Generic name
- Localized cutaneous/musculoskeletal cryotherapy unit
- Model / reference
- 120 v
- Primary DI / UDI-DI
- 00850064466027
- 510(k) Number
- FDA product code
- GEX
- GMDN term
- Localized cutaneous/musculoskeletal cryotherapy unit
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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