510(k) · Cleared
ClearedTherapeutic Massage Companion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endurance Therapeutics · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Dec 3, 2007 as substantially equivalent to K011880 (Compex S.A., 2002) and 2 other predicates after a 615-day review. Its family tree reaches back 2 generations to 1994. 151 later devices descend from it.
- Decided
- Dec 3, 2007
- Review
- 615 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K940301 (1994). 4 ancestors in all. 151 later devices descend from it, 11 citing it directly.
- Root · 2 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 1 generation backK011880 Compex SportCompex S.A. · 2002
- This deviceK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- Descendant · cites it directly · 78 of its ownK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- Descendant · cites it directly · 58 of its ownK112392 Hivox Biotek Inc.Hivox Biotek, Inc. · 2012
- Descendant · cites it directly · 55 of its ownK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- Descendant · cites it directly · 50 of its ownK110068 Model PM3030Omron Healthcare, Inc. · 2011
- Descendant · cites it directly · 33 of its ownK113037 Pain-AidPdi Works, LLC · 2012
Showing 5 of 151 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 151 · See all- K102598HI-Dow-XPHi-Dow International, Inc. · 2011 · cites it directly78descendants
- K112392Hivox Biotek Inc.Hivox Biotek, Inc. · 2012 · cites it directly58descendants
- K122744Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013 · cites it directly55descendants
- K110068Model PM3030Omron Healthcare, Inc. · 2011 · cites it directly50descendants
- K113037Pain-AidPdi Works, LLC · 2012 · cites it directly33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −1 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| 0 (this device) | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| +1 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| +1 | K112392 | Hivox Biotek Inc. | Hivox Biotek, Inc. | 2012 | — |
| +1 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| +1 | K110068 | Model PM3030 | Omron Healthcare, Inc. | 2011 | — |
| +1 | K113037 | Pain-Aid | Pdi Works, LLC | 2012 | — |
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 |
|---|---|---|
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 8 | 0 |
| 2014 | 15 | 0 |
| 2015 | 9 | 0 |
| 2016 | 6 | 0 |
| 2017 | 15 | 0 |
| 2018 | 8 | 0 |
| 2019 | 14 | 0 |
| 2020 | 11 | 0 |
| 2021 | 13 | 0 |
| 2022 | 11 | 0 |
| 2023 | 9 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 5 | 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? (3)
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 |
|---|---|---|---|
| * | K011880 | Compex SportSummary page 1…tor, Nerve, Transcutaneous, Over-the-Counter. Regulatory Class: Class 11 Product Code NUH, NGX, GZJ 3.0 Predicate Devices K01 1880 Compex Sport Sport Muscle Stimulator 21CFR890.5850 OTC K033122 Prizm Medical inc. 5000… | 2002 |
| * | K033122 | 5000Z System (Otc)Summary page 1…uct Code NUH, NGX, GZJ 3.0 Predicate Devices K01 1880 Compex Sport Sport Muscle Stimulator 21CFR890.5850 OTC K033122 Prizm Medical inc. 5000Z OTC TENS 21GFR882.5890 OTC K050174 Bio Stim Kit, Ba… | 2004 |
| * | K050174 | Bio-Stim KitSummary page 1…Sport Muscle Stimulator 21CFR890.5850 OTC K033122 Prizm Medical inc. 5000Z OTC TENS 21GFR882.5890 OTC K050174 Bio Stim Kit, Back Pain Relief System 210FR882.5890 OTC 4.0 Device Description: The… | 2005 |
What descends from it? (151)
See all 15111 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102598 | HI-Dow-XP | 2011 | 78 |
| K112392 | Hivox Biotek Inc. | 2012 | 58 |
| K122744 | Prospera Otc Tens Electronic Pulse Massager | 2013 | 55 |
| K110068 | Model PM3030 | 2011 | 50 |
| K113037 | Pain-Aid | 2012 | 33 |
| K091757 | Otc Tens for Arm and Leg Pain Relief, Model WL-2407 | 2010 | 6 |
| K120500 | The Pain Pilot (a.K.a Pain Pilot) | 2012 | 4 |
| K130723 | FDES106 Mini Tens&Ems Device,FDES106 Multi-Function Mini Tens&Ems Device,FDES105 Pain… | 2014 | 2 |
| K093999 | Arp Pov Sport | 2010 | 1 |
| K100441 | Xiniwave, Model XW-18 | 2010 | 1 |
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 13 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K102598 (Hi-Dow International, Inc., 2011) has gone furthest, with 78 descendants of its own.
- 11 other devices also cite its predicate K011880.
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. 2007, 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?
To be used for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 4 To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 1 or Auto 3 To be used for…
Read the full statement (145 words)
To be used for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 4
To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 3, 4, 5, 6 or Auto 1 or Auto 3
To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes 1, 2, 6 or Autol or Auto 4
Used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode 1 or Auto Mode 2
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060846 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060846: Therapeutic Massage Companion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060846
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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