# K250896: Aura Wave

- Pathway: 510(k) (Traditional)
- Applicant: Aura Wellness, LLC
- Decided: Dec 2, 2025 after 252 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: 8 generations back to K940301 (1994). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210174: BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set, Bemer Int AG (2021) Summary page 5.

## Most influential descendants
- K262788: Nova HD+ (2026), 0 descendants of its own

## Indications for use
The Aura Wave 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/K250896
Methodology: https://510kreport.com/methodology