510(k) · Cleared
ClearedMPP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marc Pro · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Jan 24, 2014 as substantially equivalent to K081998 (Electronic Waveform Laboratory, Inc., 2009) and 2 other predicates after a 212-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it.
- Decided
- Jan 24, 2014
- Review
- 212 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K940301 (1994). 13 ancestors in all, the oldest K813601 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 4 generations backK011880 Compex SportCompex S.A. · 2002
- 3 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 2 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 1 generation backK121757 HealthmateforeverHealthmate International, LLC · 2012
- This deviceK131910 MPPMarc Pro · 2014
- Descendant · cites it directly · 0 of its ownK160255 HBOTC Muscle and Nerve StimulatorHb Medical, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −4 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −3 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −2 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −1 | K121757 | Healthmateforever | Healthmate International, LLC | 2012 | — |
| 0 (this device) | K131910 | MPP | Marc Pro | 2014 | — |
| +1 | 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 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (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 |
|---|---|---|---|
| * | K081998 | H-Wave SportSummary page 1…§ 882.5890 (Product Code NUH) Powered Muscle Stimulator for Muscle Conditioning - OTC 21 C.F.R. § 890.5850 (Product Code NGX) Predicate Devices (K081998) (K12 1757) (K112485) Intended Use / Indications for Use The MPP is to be used for temporary relief of pain as… | 2009 |
| * | K121757 | HealthmateforeverSummary page 1…ct Code NUH) Powered Muscle Stimulator for Muscle Conditioning - OTC 21 C.F.R. § 890.5850 (Product Code NGX) Predicate Devices (K081998) (K12 1757) (K112485) Intended Use / Indications for Use The MPP is to be used for temporary relief of pain associated with sore… | 2012 |
| * | K112485 | H-WAVESummary page 1…Powered Muscle Stimulator for Muscle Conditioning - OTC 21 C.F.R. § 890.5850 (Product Code NGX) Predicate Devices (K081998) (K12 1757) (K112485) Intended Use / Indications for Use The MPP is to be used for temporary relief of pain associated with sore and aching muscles… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160255 | HBOTC Muscle and Nerve Stimulator | 2016 | 0 |
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 20 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K160255 (Hb Medical, Inc., 2016) has gone furthest, with 0 descendants of its own.
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. 2014, 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 MPP is 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 and normal household and work activities.
The MPP is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131910: MPP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131910
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