Aura Wellness Nova HD+
Aura Wellness Nova HD+ (APN-00067) is a deep-tissue electromagnetic stimulation system (FDA Class II; FDA product code SGT, Electromagnetic Stimulator For Healthy Muscle Stimulation) made by Aura Wellness, LLC, cleared under FDA 510(k) K220938 on 22 Aug 2023 and listed in FDA GUDID since 6 Sep 2023 (UDI-DI 00850026680072), active as of 2 Nov 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 | Number00850026680072 | Date6 Sep 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220938 | Date22 Aug 2023 | StatusActive |
Official records
- AccessGUDID record 00850026680072
- FDA 510(k) database K220938
Across registries
- FDA 510(k) K220938 decided 22 Aug 2023 Active
- FDA GUDID UDI-DI 00850026680072 listed 6 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K220938
- Listed FDA GUDID 00850026680072
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aura Wellness
- Generic name
- Deep-tissue electromagnetic stimulation system, professional
- Model / Ref / Catalog
- Nova HD+, APN-00067
- Primary DI / UDI-DI
- 00850026680072
- FDA product code
- SGT
- GMDN term
- Deep-tissue electromagnetic stimulation system, professional
- Device class
- Class II
- Regulation number
- 890.5850
- GUDID distribution status
- In Commercial Distribution