510(k) · Cleared
ClearedHeat Pain Pro
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 Jun 3, 2016 as substantially equivalent to K141978 (Omron Healthcare, Inc., 2014) after a 136-day review. Its family tree reaches back 6 generations to 1994. 8 later devices descend from it.
- Decided
- Jun 3, 2016
- Review
- 136 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K940301 (1994). 9 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 5 generations backK011880 Compex SportCompex S.A. · 2002
- 4 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 3 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 2 generations backK121757 HealthmateforeverHealthmate International, LLC · 2012
- 1 generation backK141978 Maxpower ReliefOmron Healthcare, Inc. · 2014
- This deviceK160115 Heat Pain ProOmron Healthcare, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK190783 Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 2020
- Descendant · 2 generations on · 1 of its ownK211942 Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623…Shenzhen Osto Technology Company Limited · 2021
- Descendant · 2 generations on · 1 of its ownK210756 Neck Care Therapy, Model: AST-905A, AST-905D, AST-905HShenzhen Osto Technology Company Limited · 2021
- Descendant · 2 generations on · 0 of its ownK223428 Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A…Shenzhen Leqing Medical Instrument Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK221092 Transcutaneous Electrical Nerve Stimulator Model: ST-304Shenzhen Future Electronic Co., Ltd. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K190783Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 2020 · cites it directly6descendants
- K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited · 2021 · 2 generations on1descendant
- K210756Neck Care Therapy, Model: AST-905A, AST-905D, AST-905HShenzhen Osto Technology Company Limited · 2021 · 2 generations on1descendant
- K223428Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A…Shenzhen Leqing Medical Instrument Co., Ltd. · 2023 · 2 generations on0descendants
- K221092Transcutaneous Electrical Nerve Stimulator Model: ST-304Shenzhen Future Electronic Co., Ltd. · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −5 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −4 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −3 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −2 | K121757 | Healthmateforever | Healthmate International, LLC | 2012 | — |
| −1 | K141978 | Maxpower Relief | Omron Healthcare, Inc. | 2014 | — |
| 0 (this device) | K160115 | Heat Pain Pro | Omron Healthcare, Inc. | 2016 | — |
| +1 | K190783 | Health Expert Electronic Stimulator (model: AST-300L) | Shenzhen Osto Technology Company Limited | 2020 | — |
| +2 | K211942 | Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) | Shenzhen Osto Technology Company Limited | 2021 | — |
| +2 | K210756 | Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H | Shenzhen Osto Technology Company Limited | 2021 | — |
| +2 | K223428 | Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A… | Shenzhen Leqing Medical Instrument Co., Ltd. | 2023 | — |
| +3 | K221092 | Transcutaneous Electrical Nerve Stimulator Model: ST-304 | Shenzhen Future Electronic Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K141978 | Maxpower ReliefSummary page 4…r, nerve, transcutaneous, over-the-counter Device Name: Heat Pain Pro Predicate Device: K141978 – Omron – PM3032 Reference Device: K070299 – ezFit Technology – ezFit Digital Heating TENS Device Description… | 2014 |
| † | K070299 | Ezfit Digital Heating Tens (Model NO.: HR-661/UC-101) | 2007 |
What descends from it? (8)
2 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 22 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K190783 (Shenzhen Osto Technology Company Limited, 2020) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K141978.
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. 2016, 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 Omron Heat Pain Pro is intended for:
The relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities.
Environments of Use: Clinics, hospital and home environments
Patient Population: Adult
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160115: Heat Pain Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160115
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