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 Jul 14, 2025 as substantially equivalent to K220601 (Zimmer Medizinsysteme GmbH, 2022) after a 73-day review. Its family tree reaches back 7 generations to 2007.
- Decided
- Jul 14, 2025
- Review
- 73 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K062439 (2007). No later device cites it as a predicate yet.
- Root · 7 generations backK062439 Powertone, Model PT-11Johari Digital Healthcare, Ltd. · 2007
- 6 generations backK131291 Torc BodyJohari Digital Healthcare, Ltd. · 2013
- 5 generations backK163165 AM-100BTL Industries, Inc. · 2017
- 4 generations backK180813 BTL 799-2BTL Industries, Inc. · 2018
- 3 generations backK182963 emFieldProZimmer Medizinsysteme GmbH · 2019
- 2 generations backK192940 CoolToneZimmer Medizinsysteme GmbH · 2019
- 1 generation backK220601 CoolToneZimmer Medizinsysteme GmbH · 2022
- This deviceK251378 CoolToneZimmer Medizinsysteme GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K062439 | Powertone, Model PT-11 | Johari Digital Healthcare, Ltd. | 2007 | — |
| −6 | K131291 | Torc Body | Johari Digital Healthcare, Ltd. | 2013 | — |
| −5 | K163165 | AM-100 | BTL Industries, Inc. | 2017 | — |
| −4 | K180813 | BTL 799-2 | BTL Industries, Inc. | 2018 | — |
| −3 | K182963 | emFieldPro | Zimmer Medizinsysteme GmbH | 2019 | — |
| −2 | K192940 | CoolTone | Zimmer Medizinsysteme GmbH | 2019 | — |
| −1 | K220601 | CoolTone | Zimmer Medizinsysteme GmbH | 2022 | — |
| 0 (this device) | K251378 | CoolTone | Zimmer Medizinsysteme GmbH | 2025 | — |
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 |
|---|---|---|---|
| * | K220601 | CoolToneSummary page 5…scle, Powered, For Muscle Conditioning DEVICE CLASSIFICATION: Class II, 21 CFR §890.5850 PRODUCT CODE: NGX PREDICATE DEVICE: CoolTone (K220601) DEVICE DESCRIPTION: The CoolTone is a non-invasive therapeutic device. The device produces an electromagnetic field that inter… | 2022 |
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 18 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 7 ancestors has a recall.
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. 2025, 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?
. Improvement of abdominal tone, strengthening of the abdominal muscles, development for
firmer abdomen.
. Strengthening, toning and firming of buttocks and thighs.
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/K251378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251378: CoolTone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251378
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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