510(k) · Cleared
ClearedBionicGym Powered Muscle Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Currents, Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Jul 18, 2019 as substantially equivalent to K150078 (Smartmissimo Technologies Pte, Ltd., 2015) after a 290-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jul 18, 2019
- Review
- 290 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K940301 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 4 generations backK011880 Compex SportCompex S.A. · 2002
- 3 generations backK061632 Globus Premium Muscle StimulatorDomino S.R.L. · 2007
- 2 generations backK083140 Compex Sport PlusChattanooga Group · 2009
- 1 generation backK150078 PowerDot (R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile…Smartmissimo Technologies Pte, Ltd. · 2015
- This deviceK182794 BionicGym Powered Muscle StimulatorMedical Currents, Ltd. · 2019
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 | K061632 | Globus Premium Muscle Stimulator | Domino S.R.L. | 2007 | — |
| −2 | K083140 | Compex Sport Plus | Chattanooga Group | 2009 | — |
| −1 | K150078 | PowerDot (R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile Application) | Smartmissimo Technologies Pte, Ltd. | 2015 | — |
| 0 (this device) | K182794 | BionicGym Powered Muscle Stimulator | Medical Currents, Ltd. | 2019 | — |
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 |
|---|---|---|---|
| * | K150078 | PowerDot (R) PD-01 Muscle Stimulator (with PowerDot (R) Mobile Application)Summary page 4…uscle, powered, for muscle conditioning Product Code: NGX Regulatory Class: II IV. Predicate Devices PowerDot® PD-01 Muscle Stimulator (K150078). The predicate device has not been subject to any design related recalls. V. Device Description The BionicGym Powered Muscle S… | 2015 |
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 25 years and passes through 6 companies; a new generation was cleared every 5.0 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K150078.
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. 2019, 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?
BionicGym is intended to stimulate healthy muscles in order to exercise, improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182794 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182794: BionicGym Powered Muscle Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182794
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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