510(k) · Cleared
ClearedEM25 - glute toning device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hivox Biotek, Inc. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Jul 27, 2015 as substantially equivalent to K123075 (Well-Life Healthcare Limited, 2013) after a 209-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Jul 27, 2015
- Review
- 209 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010335 (2001). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 5 generations backK030708 Slendertone Flex Abdominal Training System, Type 515Bio-Medical Research, Ltd. · 2003
- 4 generations backK061914 Sport-Elec, Models Duo CT5 Slimness and CT5 SlimnessSport-Elec S.A. · 2007
- 3 generations backK081026 Body Control System Family, Body Control Duo and CT5Sport-Elec S.A. · 2008
- 2 generations backK092142 Sport-Elec Body Control System BSSport-Elec · 2010
- 1 generation backK123075 Buttock Muscle Stimulator Model WL-2413B; Buttock Muscle Stimulator…Well-Life Healthcare Limited · 2013
- This deviceK143737 EM25 - glute toning deviceHivox Biotek, Inc. · 2015
View 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 | K030708 | Slendertone Flex Abdominal Training System, Type 515 | Bio-Medical Research, Ltd. | 2003 | — |
| −4 | K061914 | Sport-Elec, Models Duo CT5 Slimness and CT5 Slimness | Sport-Elec S.A. | 2007 | — |
| −3 | K081026 | Body Control System Family, Body Control Duo and CT5 | Sport-Elec S.A. | 2008 | — |
| −2 | K092142 | Sport-Elec Body Control System BS | Sport-Elec | 2010 | — |
| −1 | K123075 | Buttock Muscle Stimulator Model WL-2413B; Buttock Muscle Stimulator Mode… | Well-Life Healthcare Limited | 2013 | — |
| 0 (this device) | K143737 | EM25 - glute toning device | Hivox Biotek, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K123075 | Buttock Muscle Stimulator Model WL-2413B; Buttock Muscle Stimulator Mode WL-2413ESummary page 4…Well-Life Healthcare Limited. Regulation number: 890.5850 Product Code: NGX 510(k) Number: K123075 Hivox Biotek, Inc. EM25 - glute toning device 510(k) Notification, K1… | 2013 |
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 14 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K123075.
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. 2015, 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 EM25 - glute toning device is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the purpose of improvement of muscle tone of the buttocks muscles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143737: EM25 - glute toning device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143737
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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