510(k) · Cleared
Recalled · 2008RS-4I Muscle Stimulator Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rs Medical · IPF Stimulator, Muscle, Powered
Cleared on Sep 12, 2003 as substantially equivalent to K000114 (Rs Medical, 2000) after a 15-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it. It has been recalled once.
- Decided
- Sep 12, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- IPF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000114 (2000). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK000114 RS-4M+Muscle StimulatorRs Medical · 2000
- This deviceK032652 RS-4I Muscle Stimulator FamilyRs Medical · 2003
- Descendant · cites it directly · 1 of its ownK112348 RS-4I Muscle StimulatorRs Medical · 2012
- Descendant · 2 generations on · 0 of its ownK221958 Flex-MIEmsi, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK062325 RS-4I Muscle Stimulator FamilyRs Medical · 2007
- Descendant · cites it directly · 0 of its ownK034005 SDS-4ISkylark Device & Systems Co., Ltd. · 2004
Most influential descendants
Showing 4 of 4 · See all- K112348RS-4I Muscle StimulatorRs Medical · 2012 · cites it directly1descendant
- K221958Flex-MIEmsi, Inc. · 2022 · 2 generations on0descendants
- K062325RS-4I Muscle Stimulator FamilyRs Medical · 2007 · cites it directly0descendants
- K034005SDS-4ISkylark Device & Systems Co., Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000114 | RS-4M+Muscle Stimulator | Rs Medical | 2000 | — |
| 0 (this device) | K032652 | RS-4I Muscle Stimulator Family | Rs Medical | 2003 | — |
| +1 | K112348 | RS-4I Muscle Stimulator | Rs Medical | 2012 | — |
| +2 | K221958 | Flex-MI | Emsi, Inc. | 2022 | — |
| +1 | K062325 | RS-4I Muscle Stimulator Family | Rs Medical | 2007 | — |
| +1 | K034005 | SDS-4I | Skylark Device & Systems Co., Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K000114 | RS-4M+Muscle Stimulator | 2000 |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 11, 2008 | Not classified | Z-0323-2011 | Other | The charge current is leaking through two Diodes, which are supposed to block the reverse current, when the device is warm during the main battery charge operation, it then causes the lithium battery to swell around two years of use and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
Muscle Stimulation, Interferential and Non-Interferential Modality
Relax muscle spasms
Prevent or retard disuse atrophy
Maintain or increase range of motion
Increase local blood circulation
Re-educate muscle
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Pain Relief, Interferential Current Modality
Relieve acute pain
Relieve and manage chronic pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032652 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032652: RS-4I Muscle Stimulator Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032652
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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