510(k) · Cleared
ClearedAura Wave
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aura Wellness, LLC · SGT Electromagnetic Stimulator For Healthy Muscle Stimulation
Cleared on Dec 2, 2025 as substantially equivalent to K210174 (Bemer Int AG, 2021) after a 252-day review. Its family tree reaches back 8 generations to 1994. 1 later device descends from it.
- Decided
- Dec 2, 2025
- Review
- 252 days
- Class
- Class II
- Product code
- SGT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K940301 (1994). 25 ancestors in all, the oldest K872976 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 7 generations backK011880 Compex SportCompex S.A. · 2002
- 6 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 5 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 4 generations backK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- 3 generations backK143207 Revitive IX (OTC)Actegy, Ltd. · 2015
- 2 generations backK151834 BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · Recalled
- 1 generation backK210174 BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2021
- This deviceK250896 Aura WaveAura Wellness, LLC · 2025
- Descendant · cites it directly · 0 of its ownK262788 Nova HD+Aura Wellness, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K262788Nova HD+Aura Wellness, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −7 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −6 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −5 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −4 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| −3 | K143207 | Revitive IX (OTC) | Actegy, Ltd. | 2015 | — |
| −2 | K151834 | BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2017 | 1 |
| −1 | K210174 | BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2021 | — |
| 0 (this device) | K250896 | Aura Wave | Aura Wellness, LLC | 2025 | — |
| +1 | K262788 | Nova HD+ | Aura Wellness, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SGT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new SGT device
- #1 K262788 Nova HD+score 14.3 · 9 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K210174 | BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetSummary page 5…SGT Device Panel: Neurological and Physical Medicine Devices III Predicate Device Bemer Classic Set and Bemer Pro-Set (K210174) IV Device Description The Aura Wave system is a noninvasive physical medicine device that uses electrically generated ma… | 2021 |
| † | K220938 | Nova HD+ | 2023 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262788 | Nova HD+ | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 8 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K262788 (Aura Wellness, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K210174.
How does its category compare?
All SGT devicesSGT Electromagnetic Stimulator For Healthy Muscle Stimulation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SGT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SGT
Too few SGT 510(k)s in any year since 2007 to give a median.
Recalls per year · SGT
No recall names SGT since 2007.
Adverse event reports per year · SGT
No MAUDE report names SGT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250896: Aura Wave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250896
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026