510(k) · Cleared
ClearedSys*Stim 208 and 208A
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 May 30, 2003 as substantially equivalent to K880235 (Chattanooga Group, Inc., 1988) after a 60-day review. Its family tree reaches back 1 generation to 1988. 18 later devices descend from it.
- Decided
- May 30, 2003
- Review
- 60 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880235 (1988). 18 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK880235 Intelect Model 120Chattanooga Group, Inc. · 1988
- This deviceK031017 Sys*Stim 208 and 208AMettler Electronics Corp. · 2003
- Descendant · cites it directly · 7 of its ownK182203 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · 2 generations on · 4 of its ownK191151 JKH Stimulator PlusJkh USA, LLC · 2019
- Descendant · cites it directly · 4 of its ownK053266 Myotrac InfinitiThought Technology, Ltd. · 2005
- Descendant · cites it directly · 3 of its ownK133638 GEKOFirstkind Limited · 2014
- Descendant · 2 generations on · 2 of its ownK152677 geko T-2 Neuromuscular StimulatorFirstkind Limited · 2015
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K182203JKH Stimulator PlusJkh USA, LLC · 2019 · cites it directly7descendants
- K191151JKH Stimulator PlusJkh USA, LLC · 2019 · 2 generations on4descendants
- K053266Myotrac InfinitiThought Technology, Ltd. · 2005 · cites it directly4descendants
- K133638GEKOFirstkind Limited · 2014 · cites it directly3descendants
- K152677geko T-2 Neuromuscular StimulatorFirstkind Limited · 2015 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880235 | Intelect Model 120 | Chattanooga Group, Inc. | 1988 | — |
| 0 (this device) | K031017 | Sys*Stim 208 and 208A | Mettler Electronics Corp. | 2003 | — |
| +1 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +2 | K191151 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
| +1 | K053266 | Myotrac Infiniti | Thought Technology, Ltd. | 2005 | — |
| +1 | K133638 | GEKO | Firstkind Limited | 2014 | — |
| +2 | K152677 | geko T-2 Neuromuscular Stimulator | Firstkind Limited | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 19.7 · 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 |
|---|---|---|---|
| * | K880235 | Intelect Model 120Summary page 3…s*Stim@ 208/208A, Model ME 208/208A and Predicate Devices: ME 208 510 K # K K880235 Pre-amendment Device Name SyseStim 208 LV-110… | 1988 |
| * | — | Amrex MS322/MS324 Named without a submission number |
What descends from it? (18)
See all 184 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?
- Its one ancestor has no recall.
- Of its descendants, K182203 (Jkh USA, LLC, 2019) has gone furthest, with 7 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.
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. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain 2. Temporary relaxation of muscle spasm 3. Prevention of post-surgical phlebc+thrombosis through immediate siimulation of calf muscles 4. Increasing local blood circulation 5. Prevention or retardation of disuse atrophy 6. Muscle re-education 7. Maintaining or increasing range of motion 1. Symptomatic relief of chronic intractable pain, acute post…
Read the full statement (110 words)
1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
2. Temporary relaxation of muscle spasm
3. Prevention of post-surgical phlebc+thrombosis through immediate siimulation of calf muscles
4. Increasing local blood circulation
5. Prevention or retardation of disuse atrophy
6. Muscle re-education
7. Maintaining or increasing range of motion
1. Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
2. Temporary relaxation of muscle spasm
3. Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
4. Increasing local blood circulation
5. Prevention or retardation of disuse atrophy
6. Muscle re-education
7. Maintaining or increasing range of motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031017 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031017: Sys*Stim 208 and 208A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031017
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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