510(k) · Cleared
ClearedBody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A-1 Engineering · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Feb 26, 2019 as substantially equivalent to K123158 (Ion Genius, Inc., 2013) and 1 other predicate after a 172-day review. Its family tree reaches back 5 generations to 1994. 5 later devices descend from it.
- Decided
- Feb 26, 2019
- Review
- 172 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K940301 (1994). 6 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- 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 backK143551 Compex Wireless USADjo, LLC · 2015
- This deviceK182440 Body SystemA-1 Engineering · 2019
- Descendant · cites it directly · 2 of its ownK213308 Venus BlissMAXVenus Concept USA, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK220592 Venus BlissMAXVenus Concept USA, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK200545 Legend Pro DMAPollogen, Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK252845 Venus Nova (FP-2001)Venus Concept, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK233470 Deka LilyEl.En S.P.A. · 2023
Most influential descendants
Showing 5 of 5 · See all- K213308Venus BlissMAXVenus Concept USA, Inc. · 2022 · cites it directly2descendants
- K220592Venus BlissMAXVenus Concept USA, Inc. · 2022 · 2 generations on1descendant
- K200545Legend Pro DMAPollogen, Ltd. · 2021 · cites it directly1descendant
- K252845Venus Nova (FP-2001)Venus Concept, Inc. · 2025 · 3 generations on0descendants
- K233470Deka LilyEl.En S.P.A. · 2023 · 2 generations on0descendants
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 | K143551 | Compex Wireless USA | Djo, LLC | 2015 | — |
| 0 (this device) | K182440 | Body System | A-1 Engineering | 2019 | — |
| +1 | K213308 | Venus BlissMAX | Venus Concept USA, Inc. | 2022 | — |
| +2 | K220592 | Venus BlissMAX | Venus Concept USA, Inc. | 2022 | — |
| +1 | K200545 | Legend Pro DMA | Pollogen, Ltd. | 2021 | — |
| +3 | K252845 | Venus Nova (FP-2001) | Venus Concept, Inc. | 2025 | — |
| +2 | K233470 | Deka Lily | El.En S.P.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K123158 | Ion Magnum GeniusSummary page 5…nt. Predicate Device: The Body System is substantially equivalent to the predicate devices listed below: • K123158, Ion Magnum Genius, under 21 CFR 890.5850 and Product Code NGX Pr… | 2013 |
| * | K143551 | Compex Wireless USASummary page 6…Conditioning Premarket Notification: K123158 Manufacturer: Ion Genius, Inc. • K143551, Compex Wireless USA, under 21 CFR 890.5850 and Product Code NGX… | 2015 |
What descends from it? (5)
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 25 years and passes through 6 companies; a new generation was cleared every 5.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K213308 (Venus Concept USA, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K123158.
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?
The Body System is intended for muscle conditioning to stimulate healthy muscles.
The Body System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The Body System is intended to be operated by a trained professional who is present to monitor treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182440: Body System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182440
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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