510(k) · Cleared
ClearedGymform Abs-a-Round
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 Aug 15, 2013 as substantially equivalent to K102295 (Leto Enterprises Incorporation, 2011) and 4 other predicates after a 213-day review. Its family tree reaches back 6 generations to 2001. 3 later devices descend from it.
- Decided
- Aug 15, 2013
- Review
- 213 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K010335 (2001). 23 ancestors in all, the oldest K940301 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 5 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 4 generations backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- 3 generations backK072553 System-Arms, Model 390,E60Bio-Medical Research, Ltd. · 2007
- 2 generations backK091865 Sport-Elec Body Control SystemSport-Elec · 2009
- 1 generation backK092476 Sport-Elec Body Control System, Model 4MSport-Elec · 2010
- This deviceK130074 Gymform Abs-a-RoundWell Brain International, Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK142055 Gymform Abs & CoreWell Brain International, Ltd. · 2015
- Descendant · cites it directly · 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 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −5 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −4 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| −3 | K072553 | System-Arms, Model 390,E60 | Bio-Medical Research, Ltd. | 2007 | — |
| −2 | K091865 | Sport-Elec Body Control System | Sport-Elec | 2009 | — |
| −1 | K092476 | Sport-Elec Body Control System, Model 4M | Sport-Elec | 2010 | — |
| 0 (this device) | K130074 | Gymform Abs-a-Round | Well Brain International, Ltd. | 2013 | — |
| +1 | K142055 | Gymform Abs & Core | Well Brain International, Ltd. | 2015 | — |
| +1 | 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 |
|---|---|---|
| 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K102295 | X2ABS Dual Channel Fitness BeltSummary page 2…al Ltd. Subject Device: C YMFORMe ABS-A-ROUND, Model. VDPGYCOIND00176 File No.: 5170k) submission report (Vl. 0), Chapters6 Number K102295 K1 11781 K1 11476 K122744 K092476 Product INGX NGX NOX… | 2011 |
| * | K111781 | Gymform Dual Flex Belt Model WB-162Summary page 2…ct Device: C YMFORMe ABS-A-ROUND, Model. VDPGYCOIND00176 File No.: 5170k) submission report (Vl. 0), Chapters6 Number K102295 K1 11781 K1 11476 K122744 K092476 Product INGX NGX NOX NGX… | 2012 |
| * | K111476 | Contour Technology Muscle StimulatorSummary page 2…RMe ABS-A-ROUND, Model. VDPGYCOIND00176 File No.: 5170k) submission report (Vl. 0), Chapters6 Number K102295 K1 11781 K1 11476 K122744 K092476 Product INGX NGX NOX NGX NGX… | 2012 |
| * | K122744 | Prospera Otc Tens Electronic Pulse Massager Cleared while this submission was under review Summary page 2…ND, Model. VDPGYCOIND00176 File No.: 5170k) submission report (Vl. 0), Chapters6 Number K102295 K1 11781 K1 11476 K122744 K092476 Product INGX NGX NOX NGX NGX Code… | 2013 |
| * | K092476 | Sport-Elec Body Control System, Model 4MSummary page 2…PGYCOIND00176 File No.: 5170k) submission report (Vl. 0), Chapters6 Number K102295 K1 11781 K1 11476 K122744 K092476 Product INGX NGX NOX NGX NGX Code Reulat… | 2010 |
What descends from it? (3)
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 12 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 23 ancestors has a recall.
- Of its descendants, K142055 (Well Brain International, Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K102295.
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. 2013, 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® ABS-A-ROUND is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS-A-ROUND may be considered a technique or method for muscle training. The 3-area belt is intended for use on the muscles in abdomen, left waist and right waist alternately. The Mini belt accessory is intended for use on the muscles in arms, legs (lower extremities), thighs and buttocks areas separately.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130074 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130074: Gymform Abs-a-Round.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130074
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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