510(k) · Cleared
ClearedSport-Elec Body Control System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sport-Elec · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Nov 13, 2009 as substantially equivalent to K081026 (Sport-Elec S.A., 2008) and 2 other predicates after a 147-day review. Its family tree reaches back 4 generations to 2001. 23 later devices descend from it.
- Decided
- Nov 13, 2009
- Review
- 147 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K010335 (2001). 7 ancestors in all. 23 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 3 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 2 generations backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- 1 generation backK072553 System-Arms, Model 390,E60Bio-Medical Research, Ltd. · 2007
- This deviceK091865 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
- Descendant · 4 generations on · 4 of its ownK200382 BTL-703-2Btl · 2021
- Descendant · 2 generations on · 3 of its ownK130074 Gymform Abs-a-RoundWell Brain International, Ltd. · 2013
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- 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
- K200382BTL-703-2Btl · 2021 · 4 generations on4descendants
- K130074Gymform Abs-a-RoundWell Brain International, Ltd. · 2013 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −3 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −2 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| −1 | K072553 | System-Arms, Model 390,E60 | Bio-Medical Research, Ltd. | 2007 | — |
| 0 (this device) | 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 | — |
| +4 | K200382 | BTL-703-2 | Btl | 2021 | — |
| +2 | K130074 | Gymform Abs-a-Round | Well Brain International, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K081026 | Body Control System Family, Body Control Duo and CT5Summary page 1…wered Muscle Stimulator 3 Predicate devices SPORT-ELEC Body Control System, manufactured by Sport-Elec REF BCS K 081026 Cleared Nov 5ti 2008 and: Slendertone System-Arms K 072553 Cleared Dec 1 4 th 2007… | 2008 |
| * | K072553 | System-Arms, Model 390,E60Summary page 1…m, manufactured by Sport-Elec REF BCS K 081026 Cleared Nov 5ti 2008 and: Slendertone System-Arms K 072553 Cleared Dec 1 4 th 2007 Slendlertone flex bottom and thighs toning system K022855 Cleared… | 2007 |
| * | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511Summary page 1…Slendertone System-Arms K 072553 Cleared Dec 1 4 th 2007 Slendlertone flex bottom and thighs toning system K022855 Cleared March 0 6th 2003 4 Description Body… | 2003 |
What descends from it? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092476 | Sport-Elec Body Control System, Model 4M | 2010 | 22 |
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 8 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K092476 (Sport-Elec, 2010) has gone furthest, with 22 descendants of its own.
- 3 other devices also cite its predicate K081026.
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. 2009, 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 System is indicated for the improvement of arms and thighs muscles tone, for strengthening of arms and thighs 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/K091865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091865: Sport-Elec Body Control System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091865
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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