510(k) · Cleared
ClearedBTL-703-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Btl · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Jan 6, 2021 as substantially equivalent to K190456 (BTL Industries, Inc., 2019) after a 323-day review. Its family tree reaches back 8 generations to 2001. 4 later devices descend from it.
- Decided
- Jan 6, 2021
- Review
- 323 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K010335 (2001). 19 ancestors in all, the oldest K952089 (1995). 4 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 7 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 6 generations backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- 5 generations backK072553 System-Arms, Model 390,E60Bio-Medical Research, Ltd. · 2007
- 4 generations backK091865 Sport-Elec Body Control SystemSport-Elec · 2009
- 3 generations backK092476 Sport-Elec Body Control System, Model 4MSport-Elec · 2010
- 2 generations backK182106 BTL 799-2TBTL Industries, Inc. · 2018
- 1 generation backK190456 BTL 799-2LBTL Industries, Inc. · 2019
- This deviceK200382 BTL-703-2Btl · 2021
- Descendant · cites it directly · 2 of its ownK240234 BTL-899MSBTL Industries, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK253408 CoolToneZimmer Medizinsysteme GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK251594 truFlexSyrma Johari Medtech Limited · 2025
- Descendant · cites it directly · 0 of its ownK232409 Electromagnetic Stimulation SystemsShanghai Apolo Medical Technology Co., Ltd. · 2024
Most influential descendants
Showing 4 of 4 · See all- K240234BTL-899MSBTL Industries, Inc. · 2024 · cites it directly2descendants
- K253408CoolToneZimmer Medizinsysteme GmbH · 2026 · 2 generations on0descendants
- K251594truFlexSyrma Johari Medtech Limited · 2025 · 2 generations on0descendants
- K232409Electromagnetic Stimulation SystemsShanghai Apolo Medical Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −7 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −6 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| −5 | K072553 | System-Arms, Model 390,E60 | Bio-Medical Research, Ltd. | 2007 | — |
| −4 | K091865 | Sport-Elec Body Control System | Sport-Elec | 2009 | — |
| −3 | K092476 | Sport-Elec Body Control System, Model 4M | Sport-Elec | 2010 | — |
| −2 | K182106 | BTL 799-2T | BTL Industries, Inc. | 2018 | — |
| −1 | K190456 | BTL 799-2L | BTL Industries, Inc. | 2019 | — |
| 0 (this device) | K200382 | BTL-703-2 | Btl | 2021 | — |
| +1 | K240234 | BTL-899MS | BTL Industries, Inc. | 2024 | — |
| +2 | K253408 | CoolTone | Zimmer Medizinsysteme GmbH | 2026 | — |
| +2 | K251594 | truFlex | Syrma Johari Medtech Limited | 2025 | — |
| +1 | K232409 | Electromagnetic Stimulation Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K190456 | BTL 799-2LSummary page 5…tially equivalent to the following product, which is already cleared for distribution in the USA under the following 510(k) Premarket Notification number: ● 799-2L (K190456) Reference Device BTL-899 The reference device has been added to this section because it is technologically similar to the BT… | 2019 |
| † | K192224 | BTL-899 | 2019 |
What descends from it? (4)
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 20 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K240234 (BTL Industries, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K190456.
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. 2021, 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?
BTL-703-2 is indicated to be used for:
* Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
» Strengthening, toning and firming of buttocks, thighs and calves.
* Improvement of muscle tone and firmness, for strengthening muscles in arms.
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/K200382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200382: BTL-703-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200382
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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