510(k) · Cleared
ClearedHealthmateforever
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthmate International, LLC · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Nov 20, 2012 as substantially equivalent to K102598 (Hi-Dow International, Inc., 2011) after a 158-day review. Its family tree reaches back 4 generations to 1994. 22 later devices descend from it.
- Decided
- Nov 20, 2012
- Review
- 158 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940301 (1994). 6 ancestors in all. 22 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 3 generations backK011880 Compex SportCompex S.A. · 2002
- 2 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 1 generation backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- This deviceK121757 HealthmateforeverHealthmate International, LLC · 2012
- Descendant · cites it directly · 10 of its ownK141978 Maxpower ReliefOmron Healthcare, Inc. · 2014
- Descendant · 2 generations on · 8 of its ownK160115 Heat Pain ProOmron Healthcare, Inc. · 2016
- Descendant · cites it directly · 8 of its ownK131290 IQ TechnologiesIq Technologies, Inc. · 2014
- Descendant · 3 generations on · 6 of its ownK190783 Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 2020
- Descendant · 2 generations on · 5 of its ownK141260 Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd. · 2014
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K141978Maxpower ReliefOmron Healthcare, Inc. · 2014 · cites it directly10descendants
- K160115Heat Pain ProOmron Healthcare, Inc. · 2016 · 2 generations on8descendants
- K131290IQ TechnologiesIq Technologies, Inc. · 2014 · cites it directly8descendants
- K190783Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 2020 · 3 generations on6descendants
- K141260Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd. · 2014 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −3 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −2 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −1 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| 0 (this device) | K121757 | Healthmateforever | Healthmate International, LLC | 2012 | — |
| +1 | K141978 | Maxpower Relief | Omron Healthcare, Inc. | 2014 | — |
| +2 | K160115 | Heat Pain Pro | Omron Healthcare, Inc. | 2016 | — |
| +1 | K131290 | IQ Technologies | Iq Technologies, Inc. | 2014 | — |
| +3 | K190783 | Health Expert Electronic Stimulator (model: AST-300L) | Shenzhen Osto Technology Company Limited | 2020 | — |
| +2 | K141260 | Electronic Pulse Stimulator | Shenzhen Jingkehui Electronic Co.., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 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 |
|---|---|---|---|
| * | K102598 | HI-Dow-XPSummary page 1…: HealthmateForever ® ' Regulation Number: 21 CFR 882.5890 OTC & 21 CFR 882.5850. Product Code: NUH & NGX Device Classification: Class Il 4. The Predicate Device ' ) K102598 _JQ-5C TENS 21 CFR 882.5890 OTC K102598 JQ-5C PMS 21 CFR 882.5850 OTC 5. Device Description Pro-8AB is portable; battery powere… | 2011 |
What descends from it? (22)
See all 225 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 18 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K141978 (Omron Healthcare, Inc., 2014) has gone furthest, with 10 descendants of its own.
- 8 other devices also cite its predicate K102598.
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. 2012, 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?
TENS (Transcutaneous Electrical Nerve Stimulation)
To be used for temporary relief of pain associated with sore and 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.
PMS (Powered Muscle Stimulator)
It is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
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/K121757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121757: Healthmateforever.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121757
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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