510(k) · Cleared
ClearedAvail
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 Oct 19, 2017 as substantially equivalent to K151035 (Philips Consumer Lifestyle, 2015) after a 101-day review. Its family tree reaches back 2 generations to 2013. 5 later devices descend from it.
- Decided
- Oct 19, 2017
- Review
- 101 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K130802 (2013). 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK130802 Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060)Shenzhen Dongdixin Technology Co., Ltd. · 2013
- 1 generation backK151035 PulseReliefPhilips Consumer Lifestyle · 2015
- This deviceK172079 AvailOmron Healthcare, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK183215 Focus TENS Therapy, Model PM710-M/-LOmron Healthcare, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK220997 Wireless TENS/EMS, Bruno, AelaZmi Elecronics, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK191075 HealyTimewaver Production GmbH · 2019
- Descendant · cites it directly · 0 of its ownK182120 Maxpower ReliefOmron Healthcare, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK181992 Heat Pain ProOmron Healthcare, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K183215Focus TENS Therapy, Model PM710-M/-LOmron Healthcare, Inc. · 2019 · cites it directly1descendant
- K220997Wireless TENS/EMS, Bruno, AelaZmi Elecronics, Ltd. · 2022 · 2 generations on0descendants
- K191075HealyTimewaver Production GmbH · 2019 · cites it directly0descendants
- K182120Maxpower ReliefOmron Healthcare, Inc. · 2019 · cites it directly0descendants
- K181992Heat Pain ProOmron Healthcare, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K130802 | Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060) | Shenzhen Dongdixin Technology Co., Ltd. | 2013 | — |
| −1 | K151035 | PulseRelief | Philips Consumer Lifestyle | 2015 | — |
| 0 (this device) | K172079 | Avail | Omron Healthcare, Inc. | 2017 | — |
| +1 | K183215 | Focus TENS Therapy, Model PM710-M/-L | Omron Healthcare, Inc. | 2019 | — |
| +2 | K220997 | Wireless TENS/EMS, Bruno, Aela | Zmi Elecronics, Ltd. | 2022 | — |
| +1 | K191075 | Healy | Timewaver Production GmbH | 2019 | — |
| +1 | K182120 | Maxpower Relief | Omron Healthcare, Inc. | 2019 | — |
| +1 | K181992 | Heat Pain Pro | Omron Healthcare, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 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 |
|---|---|---|---|
| * | K151035 | PulseReliefSummary page 5…7.92(a)(3)] The Omron Avail™ (Model PM601) TENS device (“Avail”) is substantially equivalent to the primary predicate device, the Philips Consumer Lifestyle PulseRelief (K151035) TENS, with regard to product labeling, intended use, anatomical sites, patient population, performance testing, technological ch… | 2015 |
| † | K131159 | Smartrelief | 2013 |
| † | K160115 | Heat Pain Pro | 2016 |
| † | K130114 | Painmaster MCT Patch | 2013 |
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K183215 (Omron Healthcare, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 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?
The Avail is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, legs, shoulders or feet due to strain from exercise or normal household work activities.
When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Tap, Shoulder, Arm or Leg mode of stimulation.
Environments of Use: Clinics, hospital and home environments
Patient Population: Adult
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172079: Avail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172079
Report an extraction error
Are you the manufacturer?
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