510(k) · Cleared
ClearedGymform Dual Flex Belt Model WB-162
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Brain International, Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Jul 11, 2012 as substantially equivalent to K030708 (Bio-Medical Research, Ltd., 2003) after a 383-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it.
- Decided
- Jul 11, 2012
- Review
- 383 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010335 (2001). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 1 generation backK030708 Slendertone Flex Abdominal Training System, Type 515Bio-Medical Research, Ltd. · 2003
- This deviceK111781 Gymform Dual Flex Belt Model WB-162Well Brain International, Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK130074 Gymform Abs-a-RoundWell Brain International, Ltd. · 2013
- Descendant · 2 generations on · 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 · 3 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 · 2 generations on1descendant
- K202653Gymform Total ABSWell Brain International, Ltd. · 2021 · 2 generations on0descendants
- K181728Muscle TrainerShenzhen Kentro Medical Electronics Co., Ltd. · 2018 · 3 generations on0descendants
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 | K030708 | Slendertone Flex Abdominal Training System, Type 515 | Bio-Medical Research, Ltd. | 2003 | — |
| 0 (this device) | K111781 | Gymform Dual Flex Belt Model WB-162 | Well Brain International, Ltd. | 2012 | — |
| +1 | K130074 | Gymform Abs-a-Round | Well Brain International, Ltd. | 2013 | — |
| +2 | K142055 | Gymform Abs & Core | Well Brain International, Ltd. | 2015 | — |
| +2 | K202653 | Gymform Total ABS | Well Brain International, Ltd. | 2021 | — |
| +3 | K181728 | Muscle Trainer | Shenzhen Kentro Medical Electronics Co., Ltd. | 2018 | — |
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? (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 |
|---|---|---|---|
| * | K030708 | Slendertone Flex Abdominal Training System, Type 515Summary page 1…ectric muscles stimulation (EMS) mode is the Slendertone FLEX Abdominal Training System Type 515 powered muscle stimulator; assigned with the 5 10(k) number of K030708 to Bio-Medical Research Ltd of Ireland cleared to market commercially in the United States. 4. Description of device:… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130074 | Gymform Abs-a-Round | 2013 | 3 |
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 11 years and passes through 2 companies; a new generation was cleared every 9.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K130074 (Well Brain International, Ltd., 2013) has gone furthest, with 3 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. 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 electrical muscle stimulation (EMS) mode of the Gymform Dual Flex Belt is indicated for the improvement of abdominal muscle tone, and for the development of a firmer abdomen.
The therapeutic vibrator (Vibration) mode of the Gymnform Dual Flex Belt is indicated for the promotion of muscle relaxation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111781: Gymform Dual Flex Belt Model WB-162.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111781
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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