510(k) · Cleared
ClearedPowered Muscle Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valmed, SA · IPF Stimulator, Muscle, Powered
Cleared on Apr 30, 2012 as substantially equivalent to K022175 (Valmed Corp., 2002) after a 278-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Apr 30, 2012
- Review
- 278 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K022175 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK022175 P4 PhysioValmed Corp. · 2002
- This deviceK112148 Powered Muscle StimulatorValmed, SA · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022175 | P4 Physio | Valmed Corp. | 2002 | — |
| 0 (this device) | K112148 | Powered Muscle Stimulator | Valmed, SA | 2012 | — |
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022175 | P4 PhysioSummary page 1…uct Code/Regulation: 88 GZJ, 862.5890 9. Predicate Devices This device is substantially equivalent to the following legally marketed devices: P4-PHYSIO (K022175), and Styline 882 (K092448) 10. Indications for Use The Indications for Use for the SW7SSS7m are s… | 2002 |
| Kept off the family tree | K092448 | FDA’s K092448 is Hivox Electric Stimulator Tens & Ems, HD2 Our reading of the summary gave K092448, FDA’s number for Hivox Electric Stimulator Tens & Ems, HD2 (Hivox Biotek, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Styline 882”. Kept off the family tree. Summary page 1…, 862.5890 9. Predicate Devices This device is substantially equivalent to the following legally marketed devices: P4-PHYSIO (K022175), and Styline 882 (K092448) 10. Indications for Use The Indications for Use for the SW7SSS7m are shown below: Indications for… | 2010 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K022175.
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?
Indications for EMS use are:
> Prevention or retardation of muscle disuse atrophy
> Relaxation of muscle spasms
> Increasing local blood circulation
> Muscle re-education
> Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
> Maintaining or improving range of motion of extremities
Indications for TENS use are:
> Symptomatic relief and management of chronic, intractable pain, and
> Adjunctive treatment for post-surgical and post-trauma acute pain
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/K112148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112148: Powered Muscle Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112148
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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