510(k) · Cleared
ClearedSan Shih Powered Muscle Stimulator, Model 202
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
San Shih Electrical Enterprise Co., Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Dec 6, 2007 as substantially equivalent to K023000 (Home Care Technology Co., Ltd., 2003) after a 232-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Dec 6, 2007
- Review
- 232 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023000 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK023000 Home Care Various Models of Powered Muscle Stimulator, HT-329M SeriesHome Care Technology Co., Ltd. · 2003
- This deviceK071093 San Shih Powered Muscle Stimulator, Model 202San Shih Electrical Enterprise Co., Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023000 | Home Care Various Models of Powered Muscle Stimulator, HT-329M Series | Home Care Technology Co., Ltd. | 2003 | — |
| 0 (this device) | K071093 | San Shih Powered Muscle Stimulator, Model 202 | San Shih Electrical Enterprise Co., Ltd. | 2007 | — |
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 |
|---|---|---|---|
| * | K023000 | Home Care Various Models of Powered Muscle Stimulator, HT-329M SeriesSummary page 1…or NAME: CLASSIFICATION Powered Muscle Stimulator NAME: REGULATION NUMBER: 890.5850 PREDICATED HOME CARE Powered Muscle Stimulator, K023000 DEVICE: INTENDED USE: · Relaxation of muscle spasms * Prevention or retardation of disuse… | 2003 |
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.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:
* Relaxation of muscle spasms
* Prevention or retardation of disuse atrophy
* Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
* Maintaining or increasing range of motion
Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071093 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071093: San Shih Powered Muscle Stimulator, Model 202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071093
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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