510(k) · Cleared
ClearedtruSculpt flex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johari Digital Healthcare Limited · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Dec 3, 2022 as substantially equivalent to K192039 (Johari Digital Healthcare Limited, 2020) after a 451-day review. Its family tree reaches back 3 generations to 2007. 7 later devices descend from it.
- Decided
- Dec 3, 2022
- Review
- 451 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K062439 (2007). 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK062439 Powertone, Model PT-11Johari Digital Healthcare, Ltd. · 2007
- 2 generations backK131291 Torc BodyJohari Digital Healthcare, Ltd. · 2013
- 1 generation backK192039 Torc BodyJohari Digital Healthcare Limited · 2020
- This deviceK212866 truSculpt flexJohari Digital Healthcare Limited · 2022
- Descendant · cites it directly · 4 of its ownK232455 SofWave SystemSofwave Medical, Ltd. · 2023
- Descendant · 2 generations on · 3 of its ownK240687 SofWave SystemSofwave Medical, Ltd. · 2024
- Descendant · 3 generations on · 2 of its ownK241685 SofWave SystemSofwave Medical, Ltd. · 2024
- Descendant · 4 generations on · 1 of its ownK250146 SofWave SystemSofwave Medical, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK251594 truFlexSyrma Johari Medtech Limited · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K232455SofWave SystemSofwave Medical, Ltd. · 2023 · cites it directly4descendants
- K240687SofWave SystemSofwave Medical, Ltd. · 2024 · 2 generations on3descendants
- K241685SofWave SystemSofwave Medical, Ltd. · 2024 · 3 generations on2descendants
- K250146SofWave SystemSofwave Medical, Ltd. · 2025 · 4 generations on1descendant
- K251594truFlexSyrma Johari Medtech Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K062439 | Powertone, Model PT-11 | Johari Digital Healthcare, Ltd. | 2007 | — |
| −2 | K131291 | Torc Body | Johari Digital Healthcare, Ltd. | 2013 | — |
| −1 | K192039 | Torc Body | Johari Digital Healthcare Limited | 2020 | — |
| 0 (this device) | K212866 | truSculpt flex | Johari Digital Healthcare Limited | 2022 | — |
| +1 | K232455 | SofWave System | Sofwave Medical, Ltd. | 2023 | — |
| +2 | K240687 | SofWave System | Sofwave Medical, Ltd. | 2024 | — |
| +3 | K241685 | SofWave System | Sofwave Medical, Ltd. | 2024 | — |
| +4 | K250146 | SofWave System | Sofwave Medical, Ltd. | 2025 | — |
| +1 | K251594 | truFlex | Syrma Johari Medtech Limited | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K192039 | Torc BodySummary page 4…me Torc Body Classification Name Powered Muscle Stimulator, Stimulator, Muscle, Powered, For Muscle Conditioning 510(K) No K192039 Address and Johari Digital Healthcare Ltd Registration G-582, 584 EPIP, Boranada,… | 2020 |
What descends from it? (7)
3 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 15 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K232455 (Sofwave Medical, Ltd., 2023) has gone furthest, with 4 descendants 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. 2022, 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?
truSculpt flex is indicated to be used for:
• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
• Strengthening, toning and firming of buttocks & thighs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212866 · printed Nov 3, 2026
Cite this page
510(k) Report. “K212866: truSculpt flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K212866
Report an extraction error
Are you the manufacturer?
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