FDA Product Code
FDA Product Code SGT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5850
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262788 | Nova HD+ | Aura Wellness, LLC | 2026-08-31 | Special | PDF ↗ |
| K250896 | Aura Wave | Aura Wellness, LLC | 2025-12-02 | Traditional | PDF ↗ |
Product code SGT · Class II · Physical Medicine. Data: openFDA.