510(k) · Cleared
ClearedGymform Total ABS
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 Jan 15, 2021 as substantially equivalent to K130074 (Well Brain International, Ltd., 2013) after a 123-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Jan 15, 2021
- Review
- 123 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K010335 (2001). 24 ancestors in all, the oldest K940301 (1994). No later device cites it as a predicate yet.
- Root · 7 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 6 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 5 generations backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- 4 generations backK072553 System-Arms, Model 390,E60Bio-Medical Research, Ltd. · 2007
- 3 generations backK091865 Sport-Elec Body Control SystemSport-Elec · 2009
- 2 generations backK092476 Sport-Elec Body Control System, Model 4MSport-Elec · 2010
- 1 generation backK130074 Gymform Abs-a-RoundWell Brain International, Ltd. · 2013
- This deviceK202653 Gymform Total ABSWell Brain International, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −6 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −5 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| −4 | K072553 | System-Arms, Model 390,E60 | Bio-Medical Research, Ltd. | 2007 | — |
| −3 | K091865 | Sport-Elec Body Control System | Sport-Elec | 2009 | — |
| −2 | K092476 | Sport-Elec Body Control System, Model 4M | Sport-Elec | 2010 | — |
| −1 | K130074 | Gymform Abs-a-Round | Well Brain International, Ltd. | 2013 | — |
| 0 (this device) | K202653 | Gymform Total ABS | Well Brain International, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K130074 | Gymform Abs-a-RoundSummary page 5…1|Page K202653 4. Predicate and Reference Device Information 510k K130074 K102295 K092476 K183674 Number (Primary (Reference (Reference… | 2013 |
| † | K102295 | X2ABS Dual Channel Fitness Belt | 2011 |
| † | K092476 | Sport-Elec Body Control System, Model 4M | 2010 |
| † | K183674 | Electronic Pulse Stimulator | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 24 ancestors has a recall.
- 1 other device also cites its predicate K130074.
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?
The Gymform® TOTAL ABS (Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The large belt is intended for use on the muscles in abdomen. The small belt for working the leg and arm muscles, intended for use on the muscles in arms, legs (lower extremities) and thighs areas separately.
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/K202653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202653: Gymform Total ABS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202653
Report an extraction error
Are you the manufacturer?
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