510(k) · Cleared
ClearedSlendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Medical Research Corp. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Mar 23, 2007 as substantially equivalent to K030708 (Bio-Medical Research, Ltd., 2003) and 2 other predicates after a 66-day review. Its family tree reaches back 2 generations to 2001. 52 later devices descend from it.
- Decided
- Mar 23, 2007
- Review
- 66 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K010335 (2001). 3 ancestors in all. 52 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 1 generation backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- This deviceK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- Descendant · cites it directly · 26 of its ownK092142 Sport-Elec Body Control System BSSport-Elec · 2010
- Descendant · cites it directly · 25 of its ownK072553 System-Arms, Model 390,E60Bio-Medical Research, Ltd. · 2007
- Descendant · 2 generations on · 23 of its ownK091865 Sport-Elec Body Control SystemSport-Elec · 2009
- Descendant · 2 generations on · 22 of its ownK092476 Sport-Elec Body Control System, Model 4MSport-Elec · 2010
- Descendant · cites it directly · 14 of its ownK083105 Kneehab XP Conductive Garment, Type 411Bio-Medical Research, Ltd. · 2009
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K092142Sport-Elec Body Control System BSSport-Elec · 2010 · cites it directly26descendants
- K072553System-Arms, Model 390,E60Bio-Medical Research, Ltd. · 2007 · cites it directly25descendants
- K091865Sport-Elec Body Control SystemSport-Elec · 2009 · 2 generations on23descendants
- K092476Sport-Elec Body Control System, Model 4MSport-Elec · 2010 · 2 generations on22descendants
- K083105Kneehab XP Conductive Garment, Type 411Bio-Medical Research, Ltd. · 2009 · cites it directly14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −1 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| 0 (this device) | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| +1 | K092142 | Sport-Elec Body Control System BS | Sport-Elec | 2010 | — |
| +1 | K072553 | System-Arms, Model 390,E60 | Bio-Medical Research, Ltd. | 2007 | — |
| +2 | K091865 | Sport-Elec Body Control System | Sport-Elec | 2009 | — |
| +2 | K092476 | Sport-Elec Body Control System, Model 4M | Sport-Elec | 2010 | — |
| +1 | K083105 | Kneehab XP Conductive Garment, Type 411 | Bio-Medical Research, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 6 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 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 |
|---|---|---|---|
| * | K030708 | Slendertone Flex Abdominal Training System, Type 515Summary page 1…ne Flex, Type 515 Slendertone Flex, Type 512 Manufacturer: Bio-Medical Research Ltd. Bio-Medical Research Ltd. 5 10(k) No: K030708, June 2003 K010335, Sept. 2001 System-Shorts, Type 390, E20 Name: Slendertone Flex Bottom… | 2003 |
| * | K010335 | Slendertone Flex, Model, 512Summary page 1…ne Flex, Type 512 Manufacturer: Bio-Medical Research Ltd. Bio-Medical Research Ltd. 5 10(k) No: K030708, June 2003 K010335, Sept. 2001 System-Shorts, Type 390, E20 Name: Slendertone Flex Bottom and Thigh Toning System, Type… | 2001 |
| * | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511Summary page 1…Slendertone Flex Bottom and Thigh Toning System, Type 511 Manufacturer: Bio-Medical Research Ltd. 510(k) No: K022855, March 2003 4. Description of Device System-Abs and System-Shorts are the newest product offerings from Slendertone (division o… | 2003 |
What descends from it? (52)
See all 526 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 6 years and passes through 2 companies; a new generation was cleared every 4.0 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.
- 5 other devices also cite its predicate K030708.
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. 2007, 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 improvement of abdominal muscle tone, for the strengthening of the abdominal
muscles and for the development of a firmer abdomen.
System-Shorts Type 390, E20 is indicated for the strengthening, toning and firming of the
bottom and thigh region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070142 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070142: Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070142
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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