510(k) · Cleared
ClearedHBOTC Muscle and Nerve Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hb Medical, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Sep 15, 2016 as substantially equivalent to K131910 (Marc Pro, 2014) and 3 other predicates after a 227-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Sep 15, 2016
- Review
- 227 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K940301 (1994). 15 ancestors in all, the oldest K813601 (1982). No later device cites it as a predicate yet.
- 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 backK131910 MPPMarc Pro · 2014
- This deviceK160255 HBOTC Muscle and Nerve StimulatorHb Medical, Inc. · 2016
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 | K131910 | MPP | Marc Pro | 2014 | — |
| 0 (this device) | K160255 | HBOTC Muscle and Nerve Stimulator | Hb Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K131910 | MPPSummary page 4…oning Regulation 890.5850 Class Class II Panel Physical Medicine Primary Predicate K131910 Secondary Predicate K112485 Third Predicate K103738 Fourth Predicate K1020… | 2014 |
| * | K112485 | H-WAVESummary page 4…Class Class II Panel Physical Medicine Primary Predicate K131910 Secondary Predicate K112485 Third Predicate K103738 Fourth Predicate K102051 K160255… | 2011 |
| * | K103738 | H-WAVESummary page 4…Panel Physical Medicine Primary Predicate K131910 Secondary Predicate K112485 Third Predicate K103738 Fourth Predicate K102051 K160255… | 2011 |
| * | K102051 | Pain BuddySummary page 4…Primary Predicate K131910 Secondary Predicate K112485 Third Predicate K103738 Fourth Predicate K102051 K160255 2 of 7 Description Th… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 companies; a new generation was cleared every 3.4 years on median.
- None of the 15 ancestors has a recall.
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?
Transcutaneous Electrical Nerve Stimulation:
1. For symptomatic relief and management of chronic pain
2. For adjunctive treatment in the management of post-surgical and post-traumatic pain
3. 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 and normal household and work activities
Powered Muscle Stimulator
1. To temporarily increase local blood circulation in healthy muscles
2. For muscle conditioning by stimulating healthy muscle in order to improve or facilitate muscle performance
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160255: HBOTC Muscle and Nerve Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160255
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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