510(k) · Cleared
ClearedSofWave System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofwave Medical, Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Aug 7, 2024 as substantially equivalent to K240687 (Sofwave Medical, Ltd., 2024) and 1 other predicate after a 57-day review. Its family tree reaches back 11 generations to 1990. 2 later devices descend from it.
- Decided
- Aug 7, 2024
- Review
- 57 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K903402 (1990). 53 ancestors in all, the oldest K894834 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK903402 Geohesive (TM), Model Numbers 1022L, 1023L, 1026LMedi-Source, Inc. · 1990
- 7 generations between
- 3 generations backK222252 Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd. · 2023
- 2 generations backK223802 accufitMettler Electronics Corporation · 2023
- 1 generation backK233926 accufitMettler Electronics Corporation · 2024
- This deviceK241685 SofWave SystemSofwave Medical, Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK250146 SofWave SystemSofwave Medical, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK251746 Pure ImpactSofwave Medical, Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK903402 Geohesive (TM), Model Numbers 1022L, 1023L, 1026LMedi-Source, Inc. · 1990
- 10 generations backK963125 M and R Reusable Electrodes (Multiple)M & R Mfg., Inc. · 1997
- 9 generations backK020735 Sof-Pach Reusable Neurostimulation ElectrodesCathay International, Ltd. · 2002
- 8 generations backK080276 Self-Adhesive ElectrodesCathay Health Care Equipment Manufacturing, Inc. · 2008
- 7 generations backK090198 Jiajian Self-Adhesive ElectrodeWuxi Jiajian Medical Instrument Co., Ltd. · 2009
- 6 generations backK132998 Wandy Self-Adhesive ElectrodesWandy Rubber Industrial Co., Ltd. · 2013
- 5 generations backK160138 Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016
- 4 generations backK180865 ZMI Self-Adhesive ElectrodesZmi Electronics, Ltd. · 2018
- 3 generations backK222252 Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd. · 2023
- 2 generations backK223802 accufitMettler Electronics Corporation · 2023
- 1 generation backK233926 accufitMettler Electronics Corporation · 2024
- This deviceK241685 SofWave SystemSofwave Medical, Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K903402 | Geohesive (TM), Model Numbers 1022L, 1023L, 1026L | Medi-Source, Inc. | 1990 | — |
| −10 | K963125 | M and R Reusable Electrodes (Multiple) | M & R Mfg., Inc. | 1997 | — |
| −9 | K020735 | Sof-Pach Reusable Neurostimulation Electrodes | Cathay International, Ltd. | 2002 | — |
| −8 | K080276 | Self-Adhesive Electrodes | Cathay Health Care Equipment Manufacturing, Inc. | 2008 | — |
| −7 | K090198 | Jiajian Self-Adhesive Electrode | Wuxi Jiajian Medical Instrument Co., Ltd. | 2009 | — |
| −6 | K132998 | Wandy Self-Adhesive Electrodes | Wandy Rubber Industrial Co., Ltd. | 2013 | — |
| −5 | K160138 | Adhesive Electrodes | Gmdasz Manufacturing Co., Ltd. | 2016 | — |
| −4 | K180865 | ZMI Self-Adhesive Electrodes | Zmi Electronics, Ltd. | 2018 | — |
| −3 | K222252 | Self-adhesive Electrode | Shenzhen Roundwhale Technology Co., Ltd. | 2023 | — |
| −2 | K223802 | accufit | Mettler Electronics Corporation | 2023 | — |
| −1 | K233926 | accufit | Mettler Electronics Corporation | 2024 | — |
| 0 (this device) | K241685 | SofWave System | Sofwave Medical, Ltd. | 2024 | — |
| +1 | K250146 | SofWave System | Sofwave Medical, Ltd. | 2025 | — |
| +2 | K251746 | Pure Impact | Sofwave Medical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 NGX? 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 NGX device
- #1 K250146 SofWave Systemscore 15.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K240687 | SofWave SystemSummary page 5…NGX 21 CFR 878.4590 (Focused Ultrasound Stimulator System for Aesthetic Use), Class II, product code OHV Predicate Devices Sofwave Medical’s SofWave System (K240687) (Predicate Device) Mettler Electronics Corporation’s accufit (K233926) (Predicate Device) Hivox Biotek Inc.’s HIVOX Spop… | 2024 |
| * | K233926 | accufitSummary page 5…c Use), Class II, product code OHV Predicate Devices Sofwave Medical’s SofWave System (K240687) (Predicate Device) Mettler Electronics Corporation’s accufit (K233926) (Predicate Device) Hivox Biotek Inc.’s HIVOX Spopad EMS SP-911, SP-921 (K192264) (Reference Device) Intended Use / Indicati… | 2024 |
| † | K192264 | HIVOX Spopad EMS SP-911, SP-921 | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250146 | SofWave System | 2025 | 1 |
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 34 years and passes through 11 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 53 ancestors have a recall of any class.
- Of its descendants, K250146 (Sofwave Medical, Ltd., 2025) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NGX devicesNGX Stimulator, Muscle, Powered, For Muscle Conditioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · NGX
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGX
93in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGX
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGX
15in 2025
MAUDE reports naming product code NGX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 135 | 0 | 0 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 4 | 132 | 0 | 0 |
| 2010 | 6 | 180 | 0 | 0 |
| 2011 | 5 | 291 | 0 | 1 |
| 2012 | 3 | 362 | 0 | 0 |
| 2013 | 6 | 269 | 2 | 1 |
| 2014 | 6 | 298 | 0 | 0 |
| 2015 | 9 | 184 | 0 | 7 |
| 2016 | 4 | 240 | 0 | 21 |
| 2017 | 10 | 108 | 0 | 2 |
| 2018 | 6 | 104 | 0 | 6 |
| 2019 | 14 | 167 | 0 | 4 |
| 2020 | 11 | 207 | 0 | 7 |
| 2021 | 12 | 256 | 0 | 5 |
| 2022 | 6 | 307 | 0 | 7 |
| 2023 | 12 | 96 | 0 | 8 |
| 2024 | 12 | 207 | 0 | 11 |
| 2025 | 15 | 93 | 0 | 15 |
| 2026 | 4 | 118 | 0 | — |
What is it indicated for?
The SofWave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck region for subjects aged 22 and older. The SofWave System is also indicated for short-term improvement in the appearance of cellulite.
The Pure Impact module is indicated to be used for:
* Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
* Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241685 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241685: SofWave System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241685
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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