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 Oct 6, 2023 as substantially equivalent to K113017 (Mettler Electronics Corp., 2012) and 1 other predicate after a 291-day review. Its family tree reaches back 9 generations to 1990. 5 later devices descend from it.
- Decided
- Oct 6, 2023
- Review
- 291 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K903402 (1990). 31 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK903402 Geohesive (TM), Model Numbers 1022L, 1023L, 1026LMedi-Source, Inc. · 1990
- 5 generations between
- 3 generations backK160138 Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016
- 2 generations backK180865 ZMI Self-Adhesive ElectrodesZmi Electronics, Ltd. · 2018
- 1 generation backK222252 Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd. · 2023
- This deviceK223802 accufitMettler Electronics Corporation · 2023
- Descendant · cites it directly · 4 of its ownK233926 accufitMettler Electronics Corporation · 2024
- Descendant · 2 generations on · 2 of its ownK241685 SofWave SystemSofwave Medical, Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK250146 SofWave SystemSofwave Medical, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK251594 truFlexSyrma Johari Medtech Limited · 2025
- Descendant · 4 generations on · 0 of its ownK251746 Pure ImpactSofwave Medical, Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK903402 Geohesive (TM), Model Numbers 1022L, 1023L, 1026LMedi-Source, Inc. · 1990
- 8 generations backK963125 M and R Reusable Electrodes (Multiple)M & R Mfg., Inc. · 1997
- 7 generations backK020735 Sof-Pach Reusable Neurostimulation ElectrodesCathay International, Ltd. · 2002
- 6 generations backK080276 Self-Adhesive ElectrodesCathay Health Care Equipment Manufacturing, Inc. · 2008
- 5 generations backK090198 Jiajian Self-Adhesive ElectrodeWuxi Jiajian Medical Instrument Co., Ltd. · 2009
- 4 generations backK132998 Wandy Self-Adhesive ElectrodesWandy Rubber Industrial Co., Ltd. · 2013
- 3 generations backK160138 Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016
- 2 generations backK180865 ZMI Self-Adhesive ElectrodesZmi Electronics, Ltd. · 2018
- 1 generation backK222252 Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd. · 2023
- This deviceK223802 accufitMettler Electronics Corporation · 2023
Most influential descendants
Showing 5 of 5 · See all- K233926accufitMettler Electronics Corporation · 2024 · cites it directly4descendants
- K241685SofWave SystemSofwave Medical, Ltd. · 2024 · 2 generations on2descendants
- K250146SofWave SystemSofwave Medical, Ltd. · 2025 · 3 generations on1descendant
- K251594truFlexSyrma Johari Medtech Limited · 2025 · 2 generations on0descendants
- K251746Pure ImpactSofwave Medical, Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K903402 | Geohesive (TM), Model Numbers 1022L, 1023L, 1026L | Medi-Source, Inc. | 1990 | — |
| −8 | K963125 | M and R Reusable Electrodes (Multiple) | M & R Mfg., Inc. | 1997 | — |
| −7 | K020735 | Sof-Pach Reusable Neurostimulation Electrodes | Cathay International, Ltd. | 2002 | — |
| −6 | K080276 | Self-Adhesive Electrodes | Cathay Health Care Equipment Manufacturing, Inc. | 2008 | — |
| −5 | K090198 | Jiajian Self-Adhesive Electrode | Wuxi Jiajian Medical Instrument Co., Ltd. | 2009 | — |
| −4 | K132998 | Wandy Self-Adhesive Electrodes | Wandy Rubber Industrial Co., Ltd. | 2013 | — |
| −3 | K160138 | Adhesive Electrodes | Gmdasz Manufacturing Co., Ltd. | 2016 | — |
| −2 | K180865 | ZMI Self-Adhesive Electrodes | Zmi Electronics, Ltd. | 2018 | — |
| −1 | K222252 | Self-adhesive Electrode | Shenzhen Roundwhale Technology Co., Ltd. | 2023 | — |
| 0 (this device) | K223802 | accufit | Mettler Electronics Corporation | 2023 | — |
| +1 | K233926 | accufit | Mettler Electronics Corporation | 2024 | — |
| +2 | K241685 | SofWave System | Sofwave Medical, Ltd. | 2024 | — |
| +3 | K250146 | SofWave System | Sofwave Medical, Ltd. | 2025 | — |
| +2 | K251594 | truFlex | Syrma Johari Medtech Limited | 2025 | — |
| +4 | 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 | 2 | 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? (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 |
|---|---|---|---|
| * | K113017 | Sys*Stim 240Summary page 4…lass: Class II Product Code: IPF III. Predicate Device Primary Predicate Device (for the accufit): Trade Name: Mettler Sys*Stim ME 240, K113017 Common or Usual Name: powered muscle stimulator Regulation Number: 21 CFR 890.5850 Regulation Name:… | 2012 |
| * | K222252 | Self-adhesive Electrode Cleared while this submission was under review Summary page 4…IPF, GZJ, ILY, LIH Premarket Notification: Mettler Electronics K113017 (06/22/2012) Secondary Predicate Device: Self‐adhesive Electrode, K222252 for the IntelliSTIM and IntelliGEL Trade Name: Self‐adhesive Electrode Common or Usual Name:… | 2023 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233926 | accufit | 2024 | 4 |
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 33 years and passes through 10 companies; a new generation was cleared every 4.5 years on median.
- 2 of the 31 ancestors have a recall of any class.
- Of its descendants, K233926 (Mettler Electronics Corporation, 2024) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K113017.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223802 · printed Nov 3, 2026
Cite this page
510(k) Report. “K223802: accufit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K223802
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