510(k) · Cleared
Clearedaccufit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mettler Electronics Corporation · IPF Stimulator, Muscle, Powered
Cleared on Mar 21, 2024 as substantially equivalent to K223802 (Mettler Electronics Corporation, 2023) after a 99-day review. Its family tree reaches back 10 generations to 1990. 4 later devices descend from it.
- Decided
- Mar 21, 2024
- Review
- 99 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K903402 (1990). 32 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK903402 Geohesive (TM), Model Numbers 1022L, 1023L, 1026LMedi-Source, Inc. · 1990
- 6 generations between
- 3 generations backK180865 ZMI Self-Adhesive ElectrodesZmi Electronics, Ltd. · 2018
- 2 generations backK222252 Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd. · 2023
- 1 generation backK223802 accufitMettler Electronics Corporation · 2023
- This deviceK233926 accufitMettler Electronics Corporation · 2024
- Descendant · cites it directly · 2 of its ownK241685 SofWave SystemSofwave Medical, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK250146 SofWave SystemSofwave Medical, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK251594 truFlexSyrma Johari Medtech Limited · 2025
- Descendant · 3 generations on · 0 of its ownK251746 Pure ImpactSofwave Medical, Ltd. · 2025
Show all 10 generations
- Root · 10 generations backK903402 Geohesive (TM), Model Numbers 1022L, 1023L, 1026LMedi-Source, Inc. · 1990
- 9 generations backK963125 M and R Reusable Electrodes (Multiple)M & R Mfg., Inc. · 1997
- 8 generations backK020735 Sof-Pach Reusable Neurostimulation ElectrodesCathay International, Ltd. · 2002
- 7 generations backK080276 Self-Adhesive ElectrodesCathay Health Care Equipment Manufacturing, Inc. · 2008
- 6 generations backK090198 Jiajian Self-Adhesive ElectrodeWuxi Jiajian Medical Instrument Co., Ltd. · 2009
- 5 generations backK132998 Wandy Self-Adhesive ElectrodesWandy Rubber Industrial Co., Ltd. · 2013
- 4 generations backK160138 Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016
- 3 generations backK180865 ZMI Self-Adhesive ElectrodesZmi Electronics, Ltd. · 2018
- 2 generations backK222252 Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd. · 2023
- 1 generation backK223802 accufitMettler Electronics Corporation · 2023
- This deviceK233926 accufitMettler Electronics Corporation · 2024
Most influential descendants
Showing 4 of 4 · See all- K241685SofWave SystemSofwave Medical, Ltd. · 2024 · cites it directly2descendants
- K250146SofWave SystemSofwave Medical, Ltd. · 2025 · 2 generations on1descendant
- K251594truFlexSyrma Johari Medtech Limited · 2025 · cites it directly0descendants
- K251746Pure ImpactSofwave Medical, Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K903402 | Geohesive (TM), Model Numbers 1022L, 1023L, 1026L | Medi-Source, Inc. | 1990 | — |
| −9 | K963125 | M and R Reusable Electrodes (Multiple) | M & R Mfg., Inc. | 1997 | — |
| −8 | K020735 | Sof-Pach Reusable Neurostimulation Electrodes | Cathay International, Ltd. | 2002 | — |
| −7 | K080276 | Self-Adhesive Electrodes | Cathay Health Care Equipment Manufacturing, Inc. | 2008 | — |
| −6 | K090198 | Jiajian Self-Adhesive Electrode | Wuxi Jiajian Medical Instrument Co., Ltd. | 2009 | — |
| −5 | K132998 | Wandy Self-Adhesive Electrodes | Wandy Rubber Industrial Co., Ltd. | 2013 | — |
| −4 | K160138 | Adhesive Electrodes | Gmdasz Manufacturing Co., Ltd. | 2016 | — |
| −3 | K180865 | ZMI Self-Adhesive Electrodes | Zmi Electronics, Ltd. | 2018 | — |
| −2 | K222252 | Self-adhesive Electrode | Shenzhen Roundwhale Technology Co., Ltd. | 2023 | — |
| −1 | K223802 | accufit | Mettler Electronics Corporation | 2023 | — |
| 0 (this device) | K233926 | accufit | Mettler Electronics Corporation | 2024 | — |
| +1 | K241685 | SofWave System | Sofwave Medical, Ltd. | 2024 | — |
| +2 | K250146 | SofWave System | Sofwave Medical, Ltd. | 2025 | — |
| +1 | K251594 | truFlex | Syrma Johari Medtech Limited | 2025 | — |
| +3 | K251746 | Pure Impact | Sofwave Medical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 3 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 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 |
|---|---|---|---|
| * | K223802 | accufitSummary page 5…s) IPF, NGX 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed Mettler Electronics Corporation K223802 (10/06/2023) Predicate Johari Digital Healthcare Limited K192039 (03/29/2020) Reference… | 2023 |
| † | K192039 | Torc Body | 2020 |
| † | K092476 | Sport-Elec Body Control System, Model 4M | 2010 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 companies; a new generation was cleared every 4.5 years on median.
- 2 of the 32 ancestors have a recall of any class.
- Of its descendants, K241685 (Sofwave Medical, Ltd., 2024) has gone furthest, with 2 descendants of its own.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- 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/K233926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233926: accufit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233926
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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