# K262788: Nova HD+

- Pathway: 510(k) (Special)
- Applicant: Aura Wellness, LLC
- Decided: Aug 31, 2026 after 25 days
- Product code: SGT (Electromagnetic Stimulator For Healthy Muscle Stimulation)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K940301 (1994). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220938: Nova HD+, Aura Wellness, LLC (2023) Summary page 5.
- K250896: Aura Wave, Aura Wellness, LLC (2025) Summary page 5.

## Indications for use
The Nova HD+ is indicated: * To temporarily increase local blood circulation in healthy leg muscles * To stimulate healthy muscles in order to improve or facilitate muscle performance

Source page: https://510kreport.com/device/K262788
Methodology: https://510kreport.com/methodology