510(k) · Cleared
ClearedSlendertone Enervive, Model 561
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Medical Research Corp. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Mar 12, 2008 as substantially equivalent to K011880 (Compex S.A., 2002) after a 268-day review. Its family tree reaches back 2 generations to 1994. 4 later devices descend from it.
- Decided
- Mar 12, 2008
- Review
- 268 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940301 (1994). 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 1 generation backK011880 Compex SportCompex S.A. · 2002
- This deviceK071666 Slendertone Enervive, Model 561Bio-Medical Research Corp. · 2008
- Descendant · cites it directly · 0 of its ownK110057 Mini MasseuseMj Specialty Retail · 2011
- Descendant · cites it directly · 0 of its ownK102926 Gemore Muscle Conditioner;Gemore Technology Co, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK102786 Well-Life Otc Ems SystemWell-Life Healthcare Limited · 2011
- Descendant · cites it directly · 0 of its ownK083164 System-Arms, Models 390, X60Bio-Medical Research, Ltd. · 2008
Most influential descendants
Showing 4 of 4 · See all- K110057Mini MasseuseMj Specialty Retail · 2011 · cites it directly0descendants
- K102926Gemore Muscle Conditioner;Gemore Technology Co, Ltd. · 2011 · cites it directly0descendants
- K102786Well-Life Otc Ems SystemWell-Life Healthcare Limited · 2011 · cites it directly0descendants
- K083164System-Arms, Models 390, X60Bio-Medical Research, Ltd. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −1 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| 0 (this device) | K071666 | Slendertone Enervive, Model 561 | Bio-Medical Research Corp. | 2008 | — |
| +1 | K110057 | Mini Masseuse | Mj Specialty Retail | 2011 | — |
| +1 | K102926 | Gemore Muscle Conditioner; | Gemore Technology Co, Ltd. | 2011 | — |
| +1 | K102786 | Well-Life Otc Ems System | Well-Life Healthcare Limited | 2011 | — |
| +1 | K083164 | System-Arms, Models 390, X60 | Bio-Medical Research, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 3 | 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 |
|---|---|---|---|
| * | K011880 | Compex Sport | 2002 |
What descends from it? (4)
4 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 14 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K110057 (Mj Specialty Retail, 2011) has gone furthest, with 0 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. 2008, 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?
"EnerViveTM" is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. "EnerViveTw" is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the "EnerViveTm" training programs are designed for injured or ailing muscles and it's use on such muscles is contraindicated. The "EnerViveTW' electrical impulses allow triggering action potentials on…
Read the full statement (161 words)
"EnerViveTM" is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
"EnerViveTw" is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the "EnerViveTm" training programs are designed for injured or ailing muscles and it's use on such muscles is contraindicated.
The "EnerViveTW' electrical impulses allow triggering action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
The various types of muscle work that "EnerViveT"' can impose on the stimulated muscles are able to improve or facilitate muscle performance. "EnerViveTr" may therefore be considered a technique of muscle training.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071666 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071666: Slendertone Enervive, Model 561.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071666
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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