510(k) · Cleared
ClearedRS-4V Muscle Stimulator
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 Jun 18, 1999 as substantially equivalent to K953136 (Rs Medical, 1995) and 1 other predicate after a 107-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Jun 18, 1999
- Review
- 107 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K926510 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926510 | Staodyn Ems+2 | Staodyne, Inc. | 1993 | — |
| −1 | K973223 | Stellar Model HS-04 | Stellar Medical Corp. | 1998 | — |
| 0 (this device) | K990697 | RS-4V Muscle Stimulator | Rs Medical | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 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 |
|---|---|---|---|
| * | K953136 | RS-4MSummary page 1…90.5850 “Powered Muscle Stimulator”, Class 11. 3. Legally Market Predicate Devices The RS-4V is substantially equivalent' to its legally marketed predecessor the RS-4M (K953136) muscle stimulator and Stellar HS-04 (K973223) muscle stimulator. ' Any statement made in conjunction with this submission regar… | 1995 |
| * | K973223 | Stellar Model HS-04Summary page 1…3. Legally Market Predicate Devices The RS-4V is substantially equivalent' to its legally marketed predecessor the RS-4M (K953136) muscle stimulator and Stellar HS-04 (K973223) muscle stimulator. ' Any statement made in conjunction with this submission regarding a determination of substantial equivalenc… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K953136.
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 Stimulator 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
Interferential Current Modality
Relieve acute pain
Relieve and manage chronic pain
Relax muscle spasms
Maintain or increase range of motion
Increase local blood circulation
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990697 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990697: RS-4V Muscle Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990697
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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