510(k) · Cleared
ClearedIon Magnum Genius
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ion Genius, Inc. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Jun 21, 2013 as substantially equivalent to K011880 (Compex S.A., 2002) after a 255-day review. Its family tree reaches back 2 generations to 1994. 7 later devices descend from it.
- Decided
- Jun 21, 2013
- Review
- 255 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940301 (1994). 7 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 1 generation backK011880 Compex SportCompex S.A. · 2002
- This deviceK123158 Ion Magnum GeniusIon Genius, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK182440 Body SystemA-1 Engineering · 2019
- Descendant · 2 generations on · 2 of its ownK213308 Venus BlissMAXVenus Concept USA, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK220592 Venus BlissMAXVenus Concept USA, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK200545 Legend Pro DMAPollogen, Ltd. · 2021
- Descendant · 4 generations on · 0 of its ownK252845 Venus Nova (FP-2001)Venus Concept, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K182440Body SystemA-1 Engineering · 2019 · cites it directly5descendants
- K213308Venus BlissMAXVenus Concept USA, Inc. · 2022 · 2 generations on2descendants
- K220592Venus BlissMAXVenus Concept USA, Inc. · 2022 · 3 generations on1descendant
- K200545Legend Pro DMAPollogen, Ltd. · 2021 · 2 generations on1descendant
- K252845Venus Nova (FP-2001)Venus Concept, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −1 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| 0 (this device) | K123158 | Ion Magnum Genius | Ion Genius, Inc. | 2013 | — |
| +1 | K182440 | Body System | A-1 Engineering | 2019 | — |
| +2 | K213308 | Venus BlissMAX | Venus Concept USA, Inc. | 2022 | — |
| +3 | K220592 | Venus BlissMAX | Venus Concept USA, Inc. | 2022 | — |
| +2 | K200545 | Legend Pro DMA | Pollogen, Ltd. | 2021 | — |
| +4 | K252845 | Venus Nova (FP-2001) | Venus Concept, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K011880 | Compex SportSummary page 2…ipping Address: 1833 Kalakaua #3905 ' Honolulu, HI 96815 Tel: 866-25-YOUNG tel:808-385-0656 Fax: 877-26-YOUNG 1.. Compex Sport Compex, S.A. Regulation No 8390.5850 K 011880 Stimulator, muscle, powered, for muscle conditioning Product Code: NGX Action Taken to Comply with the requirements of section… | 2002 |
| † | K870426 | Axelgaard self-adhesive electrodes |
What descends from it? (7)
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 19 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K182440 (A-1 Engineering, 2019) has gone furthest, with 5 descendants of its own.
- 11 other devices also cite its predicate K011880.
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. 2013, 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?
Ion Magnum Genius is intended for muscle conditioning to stimulate healthy muscles. The Ion Magnum Genius is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Ion Magnum Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Ion Magnum Genius is only offered under prescription given by a physician licensed in the state in which he or she practices.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K123158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123158: Ion Magnum Genius.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123158
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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