510(k) · Cleared
ClearedSys*Stim 240
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mettler Electronics Corp. · IPF Stimulator, Muscle, Powered
Cleared on Jun 26, 2012 as substantially equivalent to K031077 (Chattanooga Group, 2003) and 1 other predicate after a 259-day review. Its family tree reaches back 5 generations to 2000. 9 later devices descend from it.
- Decided
- Jun 26, 2012
- Review
- 259 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001179 (2000). 11 ancestors in all, the oldest K941461 (1995). 9 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 4 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 3 generations backK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
- 2 generations backK040729 Solaris D890 Therapy ProbeDynatronics Corp. · 2004
- 1 generation backK043586 Laser Sys*Stim 540, Model ME 540Mettler Electronics Corp. · 2005
- This deviceK113017 Sys*Stim 240Mettler Electronics Corp. · 2012
- Descendant · cites it directly · 5 of its ownK223802 accufitMettler Electronics Corporation · 2023
- Descendant · 2 generations on · 4 of its ownK233926 accufitMettler Electronics Corporation · 2024
- Descendant · 3 generations on · 2 of its ownK241685 SofWave SystemSofwave Medical, Ltd. · 2024
- Descendant · 4 generations on · 1 of its ownK250146 SofWave SystemSofwave Medical, Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK213655 HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)Hilltek, LLC · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K223802accufitMettler Electronics Corporation · 2023 · cites it directly5descendants
- K233926accufitMettler Electronics Corporation · 2024 · 2 generations on4descendants
- K241685SofWave SystemSofwave Medical, Ltd. · 2024 · 3 generations on2descendants
- K250146SofWave SystemSofwave Medical, Ltd. · 2025 · 4 generations on1descendant
- K213655HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)Hilltek, LLC · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −4 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −3 | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe… | Dynatronics Corp. | 2003 | — |
| −2 | K040729 | Solaris D890 Therapy Probe | Dynatronics Corp. | 2004 | — |
| −1 | K043586 | Laser Sys*Stim 540, Model ME 540 | Mettler Electronics Corp. | 2005 | — |
| 0 (this device) | K113017 | Sys*Stim 240 | Mettler Electronics Corp. | 2012 | — |
| +1 | K223802 | accufit | Mettler Electronics Corporation | 2023 | — |
| +2 | K233926 | accufit | Mettler Electronics Corporation | 2024 | — |
| +3 | K241685 | SofWave System | Sofwave Medical, Ltd. | 2024 | — |
| +4 | K250146 | SofWave System | Sofwave Medical, Ltd. | 2025 | — |
| +1 | K213655 | HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) | Hilltek, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 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 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 19.6 · 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 |
|---|---|---|---|
| * | K031077 | Vectra Epr System and Intelect Epr SystemSummary page 1…vel Light Therapy device Predicate Devices: a. TRADE NAME: Chattanooga Group's Vectra Genisys - 2- channel electrotherapy system b. 510(k) Number: (K031077) c. TRADE NAME: Mettler Electronic Corp.'s Laser Sys*Stim 540, infrared lamp, therapeutic heating device d.… | 2003 |
| * | K043586 | Laser Sys*Stim 540, Model ME 540Summary page 1…510(k) Number: (K031077) c. TRADE NAME: Mettler Electronic Corp.'s Laser Sys*Stim 540, infrared lamp, therapeutic heating device d. 510(k) Number: (K043586) Description of Proposed Device: The new Sys*Stim@ 240 neuromuscular stimulator features nine discrete waveforms… | 2005 |
| † | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number ME 994 | 1999 |
| † | K964028 | Sys Stim 226 | 1997 |
| † | K984114 | Sys Stim 294, Model ME 294 | 1999 |
| † | K013192 | Sonicator Plus 930, Model ME 930 | 2001 |
What descends from it? (9)
3 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 12 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K223802 (Mettler Electronics Corporation, 2023) has gone furthest, with 5 descendants of its own.
- 8 other devices also cite its predicate K031077.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
1. Indications for Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Premodulated (2P3) waveforms * 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 2. Additional indications for Microcurrent…
Read the full statement (148 words)
1. Indications for Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Premodulated (2P3) waveforms
* 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
2. Additional indications for Microcurrent, Interferential (4P), Premodulated (2P3), Biphasic and TENS waveforms
* Symptomatic relief and management of chronic, intractable pain
* Post-traumatic acute pain
* Post-surgical acute pain
3. Indications for DC (Direct Current) Mode
*Relaxation of muscle spasm
4. The laser and cluster applicators of the Sys*Stim 240 emit infrared energy for:
* .Temporary increase in local blood circulation
* Temporary relief of minor muscle and joint aches, pains and stiffness
*Relaxation of muscles
*Temporary relief of muscle spasms
*Temporary relief of minor pain and stiffness associated with arthritis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113017: Sys*Stim 240.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113017
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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