510(k) · Cleared
ClearedPure Impact
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 Jul 2, 2025 as substantially equivalent to K250146 (Sofwave Medical, Ltd., 2025) after a 26-day review. Its family tree reaches back 13 generations to 1990.
- Decided
- Jul 2, 2025
- Review
- 26 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K903402 (1990). 62 ancestors in all, the oldest K894834 (1989). No later device cites it as a predicate yet.
- Root · 13 generations backK903402 Geohesive (TM), Model Numbers 1022L, 1023L, 1026LMedi-Source, Inc. · 1990
- 9 generations between
- 3 generations backK233926 accufitMettler Electronics Corporation · 2024
- 2 generations backK241685 SofWave SystemSofwave Medical, Ltd. · 2024
- 1 generation backK250146 SofWave SystemSofwave Medical, Ltd. · 2025
- This deviceK251746 Pure ImpactSofwave Medical, Ltd. · 2025
Show all 13 generations
- Root · 13 generations backK903402 Geohesive (TM), Model Numbers 1022L, 1023L, 1026LMedi-Source, Inc. · 1990
- 12 generations backK963125 M and R Reusable Electrodes (Multiple)M & R Mfg., Inc. · 1997
- 11 generations backK020735 Sof-Pach Reusable Neurostimulation ElectrodesCathay International, Ltd. · 2002
- 10 generations backK080276 Self-Adhesive ElectrodesCathay Health Care Equipment Manufacturing, Inc. · 2008
- 9 generations backK090198 Jiajian Self-Adhesive ElectrodeWuxi Jiajian Medical Instrument Co., Ltd. · 2009
- 8 generations backK132998 Wandy Self-Adhesive ElectrodesWandy Rubber Industrial Co., Ltd. · 2013
- 7 generations backK160138 Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016
- 6 generations backK180865 ZMI Self-Adhesive ElectrodesZmi Electronics, Ltd. · 2018
- 5 generations backK222252 Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd. · 2023
- 4 generations backK223802 accufitMettler Electronics Corporation · 2023
- 3 generations backK233926 accufitMettler Electronics Corporation · 2024
- 2 generations backK241685 SofWave SystemSofwave Medical, Ltd. · 2024
- 1 generation backK250146 SofWave SystemSofwave Medical, Ltd. · 2025
- This deviceK251746 Pure ImpactSofwave Medical, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K903402 | Geohesive (TM), Model Numbers 1022L, 1023L, 1026L | Medi-Source, Inc. | 1990 | — |
| −12 | K963125 | M and R Reusable Electrodes (Multiple) | M & R Mfg., Inc. | 1997 | — |
| −11 | K020735 | Sof-Pach Reusable Neurostimulation Electrodes | Cathay International, Ltd. | 2002 | — |
| −10 | K080276 | Self-Adhesive Electrodes | Cathay Health Care Equipment Manufacturing, Inc. | 2008 | — |
| −9 | K090198 | Jiajian Self-Adhesive Electrode | Wuxi Jiajian Medical Instrument Co., Ltd. | 2009 | — |
| −8 | K132998 | Wandy Self-Adhesive Electrodes | Wandy Rubber Industrial Co., Ltd. | 2013 | — |
| −7 | K160138 | Adhesive Electrodes | Gmdasz Manufacturing Co., Ltd. | 2016 | — |
| −6 | K180865 | ZMI Self-Adhesive Electrodes | Zmi Electronics, Ltd. | 2018 | — |
| −5 | K222252 | Self-adhesive Electrode | Shenzhen Roundwhale Technology Co., Ltd. | 2023 | — |
| −4 | K223802 | accufit | Mettler Electronics Corporation | 2023 | — |
| −3 | K233926 | accufit | Mettler Electronics Corporation | 2024 | — |
| −2 | K241685 | SofWave System | Sofwave Medical, Ltd. | 2024 | — |
| −1 | K250146 | SofWave System | Sofwave Medical, Ltd. | 2025 | — |
| 0 (this device) | K251746 | Pure Impact | Sofwave Medical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 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 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? (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 |
|---|---|---|---|
| * | K250146 | SofWave SystemSummary page 5…on Name: 21 CFR 890.5850 (Powered Muscle Stimulator for Muscle Conditioning) Class II Product Code NGX Predicate Devices Sofwave Medical’s SofWave System (K250146) Intended Use / Indications for Use Pure Impact is indicated to be used for: • Improvement of abdominal t… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 11 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 62 ancestors have a recall of any class.
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. 2025, 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?
* 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.
* The Pure Impact is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Pure Impact is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The various types of muscle work that the Pure Impact can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Pure Impact may therefore be considered a technique of muscle training.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251746 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251746: Pure Impact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251746
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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