510(k) · Cleared
ClearedPowerDot (R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile Application)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smartmissimo Technologies Pte, Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Sep 30, 2015 as substantially equivalent to K083140 (Chattanooga Group, 2009) after a 258-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Sep 30, 2015
- Review
- 258 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940301 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 3 generations backK011880 Compex SportCompex S.A. · 2002
- 2 generations backK061632 Globus Premium Muscle StimulatorDomino S.R.L. · 2007
- 1 generation backK083140 Compex Sport PlusChattanooga Group · 2009
- This deviceK150078 PowerDot (R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile…Smartmissimo Technologies Pte, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK253478 Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK182794 BionicGym Powered Muscle StimulatorMedical Currents, Ltd. · 2019
Most influential descendants
Showing 2 of 2 · See allView 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 | K061632 | Globus Premium Muscle Stimulator | Domino S.R.L. | 2007 | — |
| −1 | K083140 | Compex Sport Plus | Chattanooga Group | 2009 | — |
| 0 (this device) | K150078 | PowerDot (R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile Application) | Smartmissimo Technologies Pte, Ltd. | 2015 | — |
| +1 | K253478 | Motive™ Muscle Stimulator for Lower Back (OT01-1003) | Motive Health, Inc. | 2025 | — |
| +1 | K182794 | BionicGym Powered Muscle Stimulator | Medical Currents, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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 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? (1)
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 |
|---|---|---|---|
| * | K083140 | Compex Sport PlusSummary page 4…Conditioning Classification: 21 CFR 890.5850, Class II Product Code: NGX Panel: 89, Physical Medicine 5.4 Predicate Device: Compex® Sport Plus (K083140) 5.5 Device Description: PowerDot PD-01 Muscle Stimulator is a battery-powered neuromuscular stimulator intend… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 5 companies; a new generation was cleared every 6.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K253478 (Motive Health, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K083140.
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. 2015, 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?
The PowerDot PD-01 device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
The PowerDot PD-01 device and PowerDot Mobile Application are not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150078 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150078: PowerDot (R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile Application).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150078
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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