Qool-air EAM000710
Qool-air EAM000710 is a Class II device made by Quanta System SpA, cleared under FDA 510(k) K171711 on 7 Jul 2017 and listed in FDA GUDID since 4 Aug 2017 (UDI-DI 08033945936952), active as of 23 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 | Number08033945936952 | Date4 Aug 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171711 | Date7 Jul 2017 | StatusActive |
Official records
- AccessGUDID record 08033945936952
- FDA 510(k) database K171711
Across registries
- FDA 510(k) K171711 decided 7 Jul 2017 Active
- FDA GUDID UDI-DI 08033945936952 listed 4 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K171711
- Listed FDA GUDID 08033945936952
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Qool-air
- Generic name
- Localized cutaneous/musculoskeletal cryotherapy unit
- Model / reference
- EAM000710
- Primary DI / UDI-DI
- 08033945936952
- 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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