Nova HD+— 510(k) K262788
Substantially EquivalentAura Wellness, LLC
FDA 510(k) clearance K262788 for Nova HD+, Substantially Equivalent on 2026-08-31. Applicant: Aura Wellness, LLC. Device class: 2.
Summary
Nova HD+ is from Aura Wellness and is filed under product code SGT, electromagnetic stimulators for healthy muscle stimulation. The record doesn't describe the device beyond that.
Class II, 21 CFR 890.5850. Physical Medicine is both the classification panel and the review panel. It came in as a Special 510(k).
Aura Wellness filed from Louisville, Kentucky. Review took 25 calendar days (August 6 to August 31, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Aura Wellness, LLC
- Product code
- Product code SGT
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Louisville, KY, US
Recent devices under product code SGT
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