510(k) · Cleared
ClearedHi-Dow Wireless TENS/EMS System (Model HD-5N)
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 Aug 4, 2017 as substantially equivalent to K102598 (Hi-Dow International, Inc., 2011) and 1 other predicate after a 245-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- Aug 4, 2017
- Review
- 245 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K940301 (1994). 9 ancestors in all. 1 later device descends from it, 1 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 deviceK163393 Hi-Dow Wireless TENS/EMS System (Model HD-5N)Hi-Dow International, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK241785 StarFormer (M008-3T)Fotona D.O.O. · 2025
Most influential descendants
Showing 1 of 1 · See all- K241785StarFormer (M008-3T)Fotona D.O.O. · 2025 · cites it directly0descendants
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) | K163393 | Hi-Dow Wireless TENS/EMS System (Model HD-5N) | Hi-Dow International, Inc. | 2017 | — |
| +1 | K241785 | StarFormer (M008-3T) | Fotona D.O.O. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (2)
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 4…. Such use could cause electric shock, burns, electrical interference, or death. 3. The Predicate Device K102598, Hi-Dow Model JQ-5C Powered Muscle Stimulator (21 CFR 890.5850) Transcutaneous Electrical Nerve Stimulator for pain relief (21 CF… | 2011 |
| * | K130723 | FDES106 Mini Tens&Ems Device,FDES106 Multi-Function Mini Tens&Ems Device,FDES105 Pain…Summary page 4…50) Transcutaneous Electrical Nerve Stimulator for pain relief (21 CFR 882.5890) This predicate has not been subject to a design-related recall. 4. Secondary Predicate K130723, FDES106(ED406) Mini TENS&EMS Device Powered Muscle Stimulator (21 CFR 890.5850) Transcutaneous Electrical Nerve stimulator for p… | 2014 |
| † | K120398 | Witouch Pro | 2012 |
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 |
|---|---|---|---|
| K241785 | StarFormer (M008-3T) | 2025 | 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 23 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K241785 (Fotona D.O.O., 2025) has gone furthest, with 0 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. 2017, 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:
To be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper
extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS:
It is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or
facilitate muscle performance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163393 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163393: Hi-Dow Wireless TENS/EMS System (Model HD-5N).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163393
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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