510(k) · Cleared
ClearedContour Technology Muscle Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contour Technology · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on May 23, 2012 as substantially equivalent to K011880 (Compex S.A., 2002) and 2 other predicates after a 362-day review. Its family tree reaches back 3 generations to 1994. 4 later devices descend from it.
- Decided
- May 23, 2012
- Review
- 362 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K940301 (1994). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 2 generations backK011880 Compex SportCompex S.A. · 2002
- 1 generation backK031611 P4-FitnessValmed Corp. · 2004
- This deviceK111476 Contour Technology Muscle StimulatorContour Technology · 2012
- Descendant · cites it directly · 3 of its ownK130074 Gymform Abs-a-RoundWell Brain International, Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK142055 Gymform Abs & CoreWell Brain International, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK202653 Gymform Total ABSWell Brain International, Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK181728 Muscle TrainerShenzhen Kentro Medical Electronics Co., Ltd. · 2018
Most influential descendants
Showing 4 of 4 · See all- K130074Gymform Abs-a-RoundWell Brain International, Ltd. · 2013 · cites it directly3descendants
- K142055Gymform Abs & CoreWell Brain International, Ltd. · 2015 · cites it directly1descendant
- K202653Gymform Total ABSWell Brain International, Ltd. · 2021 · 2 generations on0descendants
- K181728Muscle TrainerShenzhen Kentro Medical Electronics Co., Ltd. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −2 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −1 | K031611 | P4-Fitness | Valmed Corp. | 2004 | — |
| 0 (this device) | K111476 | Contour Technology Muscle Stimulator | Contour Technology | 2012 | — |
| +1 | K130074 | Gymform Abs-a-Round | Well Brain International, Ltd. | 2013 | — |
| +1 | K142055 | Gymform Abs & Core | Well Brain International, Ltd. | 2015 | — |
| +2 | K202653 | Gymform Total ABS | Well Brain International, Ltd. | 2021 | — |
| +2 | K181728 | Muscle Trainer | Shenzhen Kentro Medical Electronics Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K011880 | Compex SportSummary page 2…ial Equivalence Contour Technology Muscle Stimulator covered by this submission is substantially equivalent to other legally marketed devices namely the following: * K01 1880, Compex Sport, Compex S.A. " K03 161 1, P4-Fitness, ValMed Corporation * K030708, Slendertone Flex 515, Bio-Medical Researc… | 2002 |
| * | K031611 | P4-FitnessSummary page 2…Stimulator covered by this submission is substantially equivalent to other legally marketed devices namely the following: * K01 1880, Compex Sport, Compex S.A. " K03 161 1, P4-Fitness, ValMed Corporation * K030708, Slendertone Flex 515, Bio-Medical Research Ltd. The Contour Technology Muscle Sti… | 2004 |
| * | K030708 | Slendertone Flex Abdominal Training System, Type 515Summary page 2…antially equivalent to other legally marketed devices namely the following: * K01 1880, Compex Sport, Compex S.A. " K03 161 1, P4-Fitness, ValMed Corporation * K030708, Slendertone Flex 515, Bio-Medical Research Ltd. The Contour Technology Muscle Stimulator and the predicate devices have the sa… | 2003 |
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 18 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K130074 (Well Brain International, Ltd., 2013) has gone furthest, with 3 descendants of its own.
- 11 other devices also cite its predicate K011880.
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. 2012, 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 Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training.
The Contour Technology Muscle Stimulator Ab Belt accessory is intended for use on abdominal muscles only for strengthening and toning of abdominal muscles.
The Contour Technology Muscle Stimulator BackPad accessory is intended for use on the lower back muscles only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111476: Contour Technology Muscle Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111476
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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