510(k) · Cleared
ClearedHI-Dow-XP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hi-Dow International, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on May 13, 2011 as substantially equivalent to K060846 (Endurance Therapeutics, 2007) and 2 other predicates after a 245-day review. Its family tree reaches back 3 generations to 1994. 78 later devices descend from it.
- Decided
- May 13, 2011
- Review
- 245 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K940301 (1994). 5 ancestors in all. 78 later devices descend from it, 9 citing it directly.
- Root · 3 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 2 generations backK011880 Compex SportCompex S.A. · 2002
- 1 generation backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- This deviceK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- Descendant · cites it directly · 55 of its ownK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- Descendant · cites it directly · 30 of its ownK121719 SM Tens & PMSHong Qiangxing (Shenzhen) Electronics Limited · 2013
- Descendant · 2 generations on · 26 of its ownK133929 Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited · 2014
- Descendant · cites it directly · 22 of its ownK121757 HealthmateforeverHealthmate International, LLC · 2012
- Descendant · 2 generations on · 17 of its ownK143207 Revitive IX (OTC)Actegy, Ltd. · 2015
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K122744Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013 · cites it directly55descendants
- K121719SM Tens & PMSHong Qiangxing (Shenzhen) Electronics Limited · 2013 · cites it directly30descendants
- K133929Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited · 2014 · 2 generations on26descendants
- K121757HealthmateforeverHealthmate International, LLC · 2012 · cites it directly22descendants
- K143207Revitive IX (OTC)Actegy, Ltd. · 2015 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −2 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −1 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| 0 (this device) | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| +1 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| +1 | K121719 | SM Tens & PMS | Hong Qiangxing (Shenzhen) Electronics Limited | 2013 | — |
| +2 | K133929 | Health Expert Elctronic Stimulator | Shenzhen Osto Technology Company Limited | 2014 | — |
| +1 | K121757 | Healthmateforever | Healthmate International, LLC | 2012 | — |
| +2 | K143207 | Revitive IX (OTC) | Actegy, Ltd. | 2015 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 6 | 0 |
| 2014 | 9 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 8 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 9 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K060846 | Therapeutic Massage CompanionSummary page 1…Trade Name: Hi-Dow Models: JQ-5C Classification Panel: Neurology Product Code: NOX NIJH Device Classification: Classo Contraindications: None 4. The Predicate Devices K060846 T1040 TENS 21ICFR 882.58900OTC K033 122 Prizm Medical Inc. 5000Z OTC… | 2007 |
| * | K033122 | 5000Z System (Otc)Summary page 1…evice Classification: Classo Contraindications: None 4. The Predicate Devices K060846 T1040 TENS 21ICFR 882.58900OTC K033 122 Prizm Medical Inc. 5000Z OTC TENS 2I1CFR 882.5890 OTC KOL 1880 Compex Sport Sport Musc… | 2004 |
| * | K011880 | Compex Sport | 2002 |
What descends from it? (78)
See all 789 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122744 | Prospera Otc Tens Electronic Pulse Massager | 2013 | 55 |
| K121719 | SM Tens & PMS | 2013 | 30 |
| K121757 | Healthmateforever | 2012 | 22 |
| K131290 | IQ Technologies | 2014 | 8 |
| K163393 | Hi-Dow Wireless TENS/EMS System (Model HD-5N) | 2017 | 1 |
| K142686 | StimPad OTC | 2014 | 0 |
| K133979 | TENS | 2014 | 0 |
| K132563 | Pinook Stimulator | 2014 | 0 |
| K122410 | I Rune (I-200L) | 2013 | 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 17 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K122744 (Prospera Corporation, 2013) has gone furthest, with 55 descendants of its own.
- 10 other devices also cite its predicate K060846.
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. 2011, 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 shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise ar normal household work activities.
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102598: HI-Dow-XP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102598
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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