510(k) · Cleared
ClearedDr.MUSIC 3s
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smartmedicaldevice Co., Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Nov 17, 2017 as substantially equivalent to K151035 (Philips Consumer Lifestyle, 2015) and 1 other predicate after a 95-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Nov 17, 2017
- Review
- 95 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K940301 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 4 generations backK011880 Compex SportCompex S.A. · 2002
- 3 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 2 generations backK110068 Model PM3030Omron Healthcare, Inc. · 2011
- 1 generation backK123866 TANYXMedecell Us, Inc. · 2013
- This deviceK172451 Dr.MUSIC 3sSmartmedicaldevice Co., Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −4 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −3 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −2 | K110068 | Model PM3030 | Omron Healthcare, Inc. | 2011 | — |
| −1 | K123866 | TANYX | Medecell Us, Inc. | 2013 | — |
| 0 (this device) | K172451 | Dr.MUSIC 3s | Smartmedicaldevice Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 NUH? 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 NUH device
- #1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 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 |
|---|---|---|---|
| * | K151035 | PulseReliefSummary page 4…rve, Transcutaneous, Over-the-Counter NUH 3) Substantially Equivalent Devices Dr.MUSIC 3s is substantially equivalent to the PulseRelief, cleared under K151035, and the Tanyx, cleared pursuant to K123866. Submitter is not aware of any design-related recalls regarding the p… | 2015 |
| * | K123866 | TANYXSummary page 4…) Substantially Equivalent Devices Dr.MUSIC 3s is substantially equivalent to the PulseRelief, cleared under K151035, and the Tanyx, cleared pursuant to K123866. Submitter is not aware of any design-related recalls regarding the predicate devices. No reference devices were used in… | 2013 |
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 23 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- None of the 9 ancestors has a recall.
- 6 other devices also cite its predicate K151035.
How does its category compare?
All NUH devicesNUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NUH
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUH
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUH
No recall names NUH since 2007.
Adverse event reports per year · NUH
7in 2025
MAUDE reports naming product code NUH, 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 | 4 | 161 | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 148 | 0 | 0 |
| 2011 | 6 | 231 | 0 | 0 |
| 2012 | 6 | 170 | 0 | 0 |
| 2013 | 10 | 189 | 0 | 1 |
| 2014 | 16 | 212 | 0 | 9 |
| 2015 | 14 | 198 | 0 | 11 |
| 2016 | 13 | 145 | 0 | 13 |
| 2017 | 17 | 155 | 0 | 21 |
| 2018 | 16 | 121 | 0 | 18 |
| 2019 | 19 | 213 | 0 | 5 |
| 2020 | 14 | 147 | 0 | 8 |
| 2021 | 14 | 198 | 0 | 7 |
| 2022 | 20 | 103 | 0 | 2 |
| 2023 | 15 | 127 | 0 | 4 |
| 2024 | 20 | 90 | 0 | 7 |
| 2025 | 15 | 119 | 0 | 7 |
| 2026 | 5 | 137 | 0 | — |
What is it indicated for?
Dr.MUSIC 3s (Model: DM-VMEOQ38) is intended to be used by adults for temporary relief of pain associated with sore/ aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities(leg) due to strain from exercise or normal household work activities and suitable for home use.
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/K172451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172451: Dr.MUSIC 3s.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172451
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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