510(k) · Cleared
ClearedCoolTone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Medizinsysteme GmbH · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Jan 16, 2026 as substantially equivalent to K240234 (BTL Industries, Inc., 2024) after a 108-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- Jan 16, 2026
- Review
- 108 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K010335 (2001). 47 ancestors in all, the oldest K872976 (1987). No later device cites it as a predicate yet.
- Root · 10 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 6 generations between
- 3 generations backK190456 BTL 799-2LBTL Industries, Inc. · 2019
- 2 generations backK200382 BTL-703-2Btl · 2021
- 1 generation backK240234 BTL-899MSBTL Industries, Inc. · 2024
- This deviceK253408 CoolToneZimmer Medizinsysteme GmbH · 2026
Show all 10 generations
- Root · 10 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 9 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 8 generations backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- 7 generations backK072553 System-Arms, Model 390,E60Bio-Medical Research, Ltd. · 2007
- 6 generations backK091865 Sport-Elec Body Control SystemSport-Elec · 2009
- 5 generations backK092476 Sport-Elec Body Control System, Model 4MSport-Elec · 2010
- 4 generations backK182106 BTL 799-2TBTL Industries, Inc. · 2018
- 3 generations backK190456 BTL 799-2LBTL Industries, Inc. · 2019
- 2 generations backK200382 BTL-703-2Btl · 2021
- 1 generation backK240234 BTL-899MSBTL Industries, Inc. · 2024
- This deviceK253408 CoolToneZimmer Medizinsysteme GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −9 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −8 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| −7 | K072553 | System-Arms, Model 390,E60 | Bio-Medical Research, Ltd. | 2007 | — |
| −6 | K091865 | Sport-Elec Body Control System | Sport-Elec | 2009 | — |
| −5 | K092476 | Sport-Elec Body Control System, Model 4M | Sport-Elec | 2010 | — |
| −4 | K182106 | BTL 799-2T | BTL Industries, Inc. | 2018 | — |
| −3 | K190456 | BTL 799-2L | BTL Industries, Inc. | 2019 | — |
| −2 | K200382 | BTL-703-2 | Btl | 2021 | — |
| −1 | K240234 | BTL-899MS | BTL Industries, Inc. | 2024 | — |
| 0 (this device) | K253408 | CoolTone | Zimmer Medizinsysteme GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 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.
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 25 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 47 ancestors has a recall of any class.
- 1 other device also cites its predicate K240234.
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. 2026, 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?
CoolTone device is indicate to be used for: . Improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen . Strengthening, toning and firming of buttocks and thighs When intended to stimulate healthy muscles to improve or facilitate muscle performance, CoolTone induces muscle contractions to enhance muscle function and may therefore be considered a technique of muscle training. In addition, the CoolTone is…
Read the full statement (138 words)
CoolTone device is indicate to be used for:
. Improvement of abdominal tone, strengthening of the abdominal muscles, development for firmer abdomen
. Strengthening, toning and firming of buttocks and thighs
When intended to stimulate healthy muscles to improve or facilitate muscle performance, CoolTone induces muscle contractions to enhance muscle function and may therefore be considered a technique of muscle training.
In addition, the CoolTone is indicated to be used for:
* Relaxation of muscle spasms
. Prevention or retardation of disuse atrophy
. Increasing local blood circulation
. Muscle reeducation
. Maintaining or increasing the range of motion
CoolTone may also be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. Furthermore, CoolTone device may be used to stimulate neuromuscular tissue for bulk muscle excitation in the legs for rehabilitative purposes.
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/K253408 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253408: CoolTone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253408
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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