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 Nov 15, 2019 as substantially equivalent to K182963 (Zimmer Medizinsysteme GmbH, 2019) after a 28-day review. Its family tree reaches back 5 generations to 2007. 2 later devices descend from it.
- Decided
- Nov 15, 2019
- Review
- 28 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K062439 (2007). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK062439 Powertone, Model PT-11Johari Digital Healthcare, Ltd. · 2007
- 4 generations backK131291 Torc BodyJohari Digital Healthcare, Ltd. · 2013
- 3 generations backK163165 AM-100BTL Industries, Inc. · 2017
- 2 generations backK180813 BTL 799-2BTL Industries, Inc. · 2018
- 1 generation backK182963 emFieldProZimmer Medizinsysteme GmbH · 2019
- This deviceK192940 CoolToneZimmer Medizinsysteme GmbH · 2019
- Descendant · cites it directly · 1 of its ownK220601 CoolToneZimmer Medizinsysteme GmbH · 2022
- Descendant · 2 generations on · 0 of its ownK251378 CoolToneZimmer Medizinsysteme GmbH · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K062439 | Powertone, Model PT-11 | Johari Digital Healthcare, Ltd. | 2007 | — |
| −4 | K131291 | Torc Body | Johari Digital Healthcare, Ltd. | 2013 | — |
| −3 | K163165 | AM-100 | BTL Industries, Inc. | 2017 | — |
| −2 | K180813 | BTL 799-2 | BTL Industries, Inc. | 2018 | — |
| −1 | K182963 | emFieldPro | Zimmer Medizinsysteme GmbH | 2019 | — |
| 0 (this device) | K192940 | CoolTone | Zimmer Medizinsysteme GmbH | 2019 | — |
| +1 | K220601 | CoolTone | Zimmer Medizinsysteme GmbH | 2022 | — |
| +2 | K251378 | CoolTone | Zimmer Medizinsysteme GmbH | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K182963 | emFieldProSummary page 4…Powered, For Muscle Conditioning DEVICE CLASSIFICATION: Class II, 21 CFR §890.5850 PRODUCT CODE: NGX III. PREDICATE DEVICE: emFieldPro (K182963) IV. DEVICE DESCRIPTION: The CoolTone is a non-invasive therapeutic device. The device produces an electromagnetic field that… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220601 | CoolTone | 2022 | 1 |
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 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K220601 (Zimmer Medizinsysteme GmbH, 2022) has gone furthest, with 1 descendant of its own.
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. 2019, 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 is indicated 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.
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/K192940 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192940: CoolTone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192940
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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