510(k) · Cleared
ClearedFlowKeepers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dk Electronics, LLC · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Apr 6, 2017 as substantially equivalent to K143207 (Actegy, Ltd., 2015) and 1 other predicate after a 426-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Apr 6, 2017
- Review
- 426 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K940301 (1994). 24 ancestors in all, the oldest K872976 (1987). 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 backK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- 1 generation backK143207 Revitive IX (OTC)Actegy, Ltd. · 2015
- This deviceK160323 FlowKeepersDk Electronics, LLC · 2017
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 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| −1 | K143207 | Revitive IX (OTC) | Actegy, Ltd. | 2015 | — |
| 0 (this device) | K160323 | FlowKeepers | Dk Electronics, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 NGX? 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 NGX device
- #1 K250146 SofWave Systemscore 15.5 · 12 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 |
|---|---|---|---|
| * | K143207 | Revitive IX (OTC)Summary page 4…Secondary – NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter) Review Panel: Physical Medicine Predicate Devices Revitive IX® (OTC), Actegy Ltd. (K143207) – NGX, NUH 21 CFR 890.5850 Pennypad PP-904 Rapid ReliefTM (OTC), HiVox Biotek, Inc. (K140650) – NUH, 21 CFR 890.5890 Intended U… | 2015 |
| * | K140650 | Hivox Electric Stimulator Otc TensSummary page 4…Physical Medicine Predicate Devices Revitive IX® (OTC), Actegy Ltd. (K143207) – NGX, NUH 21 CFR 890.5850 Pennypad PP-904 Rapid ReliefTM (OTC), HiVox Biotek, Inc. (K140650) – NUH, 21 CFR 890.5890 Intended Use/ Indications for Use Powered Muscle Stimulator • To temporarily increase local blood… | 2014 |
| † | K160508 | Electronic Pulse Stimulator | 2016 |
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 23 years and passes through 7 companies; a new generation was cleared every 3.4 years on median.
- None of the 24 ancestors has a recall.
- 3 other devices also cite its predicate K143207.
How does its category compare?
All NGX devicesNGX Stimulator, Muscle, Powered, For Muscle Conditioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NGX
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGX
93in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGX
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGX
15in 2025
MAUDE reports naming product code NGX, 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 | 7 | 135 | 0 | 0 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 4 | 132 | 0 | 0 |
| 2010 | 6 | 180 | 0 | 0 |
| 2011 | 5 | 291 | 0 | 1 |
| 2012 | 3 | 362 | 0 | 0 |
| 2013 | 6 | 269 | 2 | 1 |
| 2014 | 6 | 298 | 0 | 0 |
| 2015 | 9 | 184 | 0 | 7 |
| 2016 | 4 | 240 | 0 | 21 |
| 2017 | 10 | 108 | 0 | 2 |
| 2018 | 6 | 104 | 0 | 6 |
| 2019 | 14 | 167 | 0 | 4 |
| 2020 | 11 | 207 | 0 | 7 |
| 2021 | 12 | 256 | 0 | 5 |
| 2022 | 6 | 307 | 0 | 7 |
| 2023 | 12 | 96 | 0 | 8 |
| 2024 | 12 | 207 | 0 | 11 |
| 2025 | 15 | 93 | 0 | 15 |
| 2026 | 4 | 118 | 0 | — |
What is it indicated for?
Powered Muscle Stimulator
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance
TENS
- For temporary relief of pain associated with sore and aching muscles of the lower extremities (legs) due to strain from exercise or normal household and work activities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160323: FlowKeepers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160323
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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