510(k) · Cleared
ClearedEMS (FlexPulse, MagnaCore, Magnetika)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cpmt Laser (Canadian Pioneer Medical Technology Corporation) · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Feb 25, 2025 as substantially equivalent to K180813 (BTL Industries, Inc., 2018) after a 266-day review. Its family tree reaches back 4 generations to 2007.
- Decided
- Feb 25, 2025
- Review
- 266 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K062439 (2007). No later device cites it as a predicate yet.
- Root · 4 generations backK062439 Powertone, Model PT-11Johari Digital Healthcare, Ltd. · 2007
- 3 generations backK131291 Torc BodyJohari Digital Healthcare, Ltd. · 2013
- 2 generations backK163165 AM-100BTL Industries, Inc. · 2017
- 1 generation backK180813 BTL 799-2BTL Industries, Inc. · 2018
- This deviceK241601 EMS (FlexPulse, MagnaCore, Magnetika)Cpmt Laser (Canadian Pioneer Medical Technology Corporation) · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K062439 | Powertone, Model PT-11 | Johari Digital Healthcare, Ltd. | 2007 | — |
| −3 | K131291 | Torc Body | Johari Digital Healthcare, Ltd. | 2013 | — |
| −2 | K163165 | AM-100 | BTL Industries, Inc. | 2017 | — |
| −1 | K180813 | BTL 799-2 | BTL Industries, Inc. | 2018 | — |
| 0 (this device) | K241601 | EMS (FlexPulse, MagnaCore, Magnetika) | Cpmt Laser (Canadian Pioneer Medical Technology Corporation) | 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 |
|---|---|---|---|
| * | K180813 | BTL 799-2Summary page 5…: BTL 799-2 Regulation Number: 21CFR 890.5850 Regulation Name: Stimulator, Muscle, Powered, For Muscle Conditioning Regulatory Class: II Product code: NGX 510(k) number: K180813 Manufacturer: BTL Industries, Inc. Device Description: The Electromagnetic Stimulator Device, with models FlexPulse, MagnaCore,… | 2018 |
| † | K190456 | BTL 799-2L | 2019 |
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 6.4 years on median.
- None of the 4 ancestors has a recall.
- 5 other devices also cite its predicate K180813.
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?
The device is indicated to be used for:
* Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
* Strengthening, Toning and Firming of buttocks and thigh
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K241601: EMS (FlexPulse, MagnaCore, Magnetika).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241601
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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