510(k) · Cleared
ClearedBody Control System Family, Body Control Duo and CT5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sport-Elec S.A. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Nov 5, 2008 as substantially equivalent to K061914 (Sport-Elec S.A., 2007) after a 209-day review. Its family tree reaches back 3 generations to 2001. 31 later devices descend from it.
- Decided
- Nov 5, 2008
- Review
- 209 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010335 (2001). 31 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 2 generations backK030708 Slendertone Flex Abdominal Training System, Type 515Bio-Medical Research, Ltd. · 2003
- 1 generation backK061914 Sport-Elec, Models Duo CT5 Slimness and CT5 SlimnessSport-Elec S.A. · 2007
- This deviceK081026 Body Control System Family, Body Control Duo and CT5Sport-Elec S.A. · 2008
- Descendant · cites it directly · 26 of its ownK092142 Sport-Elec Body Control System BSSport-Elec · 2010
- Descendant · cites it directly · 23 of its ownK091865 Sport-Elec Body Control SystemSport-Elec · 2009
- Descendant · cites it directly · 22 of its ownK092476 Sport-Elec Body Control System, Model 4MSport-Elec · 2010
- Descendant · 2 generations on · 12 of its ownK182106 BTL 799-2TBTL Industries, Inc. · 2018
- Descendant · 3 generations on · 11 of its ownK190456 BTL 799-2LBTL Industries, Inc. · 2019
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K092142Sport-Elec Body Control System BSSport-Elec · 2010 · cites it directly26descendants
- K091865Sport-Elec Body Control SystemSport-Elec · 2009 · cites it directly23descendants
- K092476Sport-Elec Body Control System, Model 4MSport-Elec · 2010 · cites it directly22descendants
- K182106BTL 799-2TBTL Industries, Inc. · 2018 · 2 generations on12descendants
- K190456BTL 799-2LBTL Industries, Inc. · 2019 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −2 | K030708 | Slendertone Flex Abdominal Training System, Type 515 | Bio-Medical Research, Ltd. | 2003 | — |
| −1 | K061914 | Sport-Elec, Models Duo CT5 Slimness and CT5 Slimness | Sport-Elec S.A. | 2007 | — |
| 0 (this device) | K081026 | Body Control System Family, Body Control Duo and CT5 | Sport-Elec S.A. | 2008 | — |
| +1 | K092142 | Sport-Elec Body Control System BS | Sport-Elec | 2010 | — |
| +1 | K091865 | Sport-Elec Body Control System | Sport-Elec | 2009 | — |
| +1 | K092476 | Sport-Elec Body Control System, Model 4M | Sport-Elec | 2010 | — |
| +2 | K182106 | BTL 799-2T | BTL Industries, Inc. | 2018 | — |
| +3 | K190456 | BTL 799-2L | BTL Industries, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K061914 | Sport-Elec, Models Duo CT5 Slimness and CT5 SlimnessSummary page 1…ABDOMINAL Training System, manufactured by Sport-Elec REF CT 5 K061914 Cleared July 26 th 2007… | 2007 |
What descends from it? (31)
See all 314 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 7 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K092142 (Sport-Elec, 2010) has gone furthest, with 26 descendants of its own.
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. 2008, 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?
Body Control is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal muscles.
Contraindicated use on injured or otherwise impaired muscles
Not intended for use in any therapy or for the treatment of any medical conditions or diseases
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081026: Body Control System Family, Body Control Duo and CT5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081026
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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