510(k) · Cleared
ClearedFocus TENS Therapy, Model PM710-M/-L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Healthcare, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Sep 7, 2019 as substantially equivalent to K172079 (Omron Healthcare, Inc., 2017) after a 292-day review. Its family tree reaches back 3 generations to 2013. 1 later device descends from it.
- Decided
- Sep 7, 2019
- Review
- 292 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K130802 (2013). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK130802 Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060)Shenzhen Dongdixin Technology Co., Ltd. · 2013
- 2 generations backK151035 PulseReliefPhilips Consumer Lifestyle · 2015
- 1 generation backK172079 AvailOmron Healthcare, Inc. · 2017
- This deviceK183215 Focus TENS Therapy, Model PM710-M/-LOmron Healthcare, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK220997 Wireless TENS/EMS, Bruno, AelaZmi Elecronics, Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220997Wireless TENS/EMS, Bruno, AelaZmi Elecronics, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K130802 | Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060) | Shenzhen Dongdixin Technology Co., Ltd. | 2013 | — |
| −2 | K151035 | PulseRelief | Philips Consumer Lifestyle | 2015 | — |
| −1 | K172079 | Avail | Omron Healthcare, Inc. | 2017 | — |
| 0 (this device) | K183215 | Focus TENS Therapy, Model PM710-M/-L | Omron Healthcare, Inc. | 2019 | — |
| +1 | K220997 | Wireless TENS/EMS, Bruno, Aela | Zmi Elecronics, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K172079 | AvailSummary page 5…(S) [807.92(a)(3)] The Omron Focus TENS Model PM710-M/-L (“PM710”) is substantially equivalent to the predicate device, the Omron Avail Wireless Dual Channel TENS PM601 (K172079), with regard to product labeling, intended use, anatomical sites, patient population, performance testing, technological charact… | 2017 |
| † | K152954 | Quell | 2016 |
| † | K180956 | Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220997 | Wireless TENS/EMS, Bruno, Aela | 2022 | 0 |
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 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K220997 (Zmi Elecronics, Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K172079.
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. 2019, 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?
The device is intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities.
It is also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis.
Environments of Use: Clinics, hospital and home environments
Patient Population: Adult
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/K183215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183215: Focus TENS Therapy, Model PM710-M/-L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183215
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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