510(k) · Cleared
ClearedtruFlex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syrma Johari Medtech Limited · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Aug 28, 2025 as substantially equivalent to K212866 (Johari Digital Healthcare Limited, 2022) and 2 other predicates after a 93-day review. Its family tree reaches back 11 generations to 1990.
- Decided
- Aug 28, 2025
- Review
- 93 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K903402 (1990). 81 ancestors in all, the oldest K872976 (1987). No later device cites it as a predicate yet.
- Root · 11 generations backK903402 Geohesive (TM), Model Numbers 1022L, 1023L, 1026LMedi-Source, Inc. · 1990
- 7 generations between
- 3 generations backK222252 Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd. · 2023
- 2 generations backK223802 accufitMettler Electronics Corporation · 2023
- 1 generation backK233926 accufitMettler Electronics Corporation · 2024
- This deviceK251594 truFlexSyrma Johari Medtech Limited · 2025
Show all 11 generations
- Root · 11 generations backK903402 Geohesive (TM), Model Numbers 1022L, 1023L, 1026LMedi-Source, Inc. · 1990
- 10 generations backK963125 M and R Reusable Electrodes (Multiple)M & R Mfg., Inc. · 1997
- 9 generations backK020735 Sof-Pach Reusable Neurostimulation ElectrodesCathay International, Ltd. · 2002
- 8 generations backK080276 Self-Adhesive ElectrodesCathay Health Care Equipment Manufacturing, Inc. · 2008
- 7 generations backK090198 Jiajian Self-Adhesive ElectrodeWuxi Jiajian Medical Instrument Co., Ltd. · 2009
- 6 generations backK132998 Wandy Self-Adhesive ElectrodesWandy Rubber Industrial Co., Ltd. · 2013
- 5 generations backK160138 Adhesive ElectrodesGmdasz Manufacturing Co., Ltd. · 2016
- 4 generations backK180865 ZMI Self-Adhesive ElectrodesZmi Electronics, Ltd. · 2018
- 3 generations backK222252 Self-adhesive ElectrodeShenzhen Roundwhale Technology Co., Ltd. · 2023
- 2 generations backK223802 accufitMettler Electronics Corporation · 2023
- 1 generation backK233926 accufitMettler Electronics Corporation · 2024
- This deviceK251594 truFlexSyrma Johari Medtech Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K903402 | Geohesive (TM), Model Numbers 1022L, 1023L, 1026L | Medi-Source, Inc. | 1990 | — |
| −10 | K963125 | M and R Reusable Electrodes (Multiple) | M & R Mfg., Inc. | 1997 | — |
| −9 | K020735 | Sof-Pach Reusable Neurostimulation Electrodes | Cathay International, Ltd. | 2002 | — |
| −8 | K080276 | Self-Adhesive Electrodes | Cathay Health Care Equipment Manufacturing, Inc. | 2008 | — |
| −7 | K090198 | Jiajian Self-Adhesive Electrode | Wuxi Jiajian Medical Instrument Co., Ltd. | 2009 | — |
| −6 | K132998 | Wandy Self-Adhesive Electrodes | Wandy Rubber Industrial Co., Ltd. | 2013 | — |
| −5 | K160138 | Adhesive Electrodes | Gmdasz Manufacturing Co., Ltd. | 2016 | — |
| −4 | K180865 | ZMI Self-Adhesive Electrodes | Zmi Electronics, Ltd. | 2018 | — |
| −3 | K222252 | Self-adhesive Electrode | Shenzhen Roundwhale Technology Co., Ltd. | 2023 | — |
| −2 | K223802 | accufit | Mettler Electronics Corporation | 2023 | — |
| −1 | K233926 | accufit | Mettler Electronics Corporation | 2024 | — |
| 0 (this device) | K251594 | truFlex | Syrma Johari Medtech Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K212866 | truSculpt flexSummary page 5…ce Trade Name truSculpt Flex Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning 510(K) No K212866 Classification Product Code NGX Address and Registration Syrma Johari Medtech Limited (formerly known as… | 2022 |
| * | K233926 | accufitSummary page 5…ame accufit Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning 510(K) No K233926 Classification Product Code NGX, IPF Address and Registration Mettler Electronics Corporation… | 2024 |
| * | K240234 | BTL-899MSSummary page 6…e Trade Name Btl-899ms Classification Name Powered Muscle Stimulator 510(K) No K240234 Classification Product Code NGX, IPF Address and Registration BTL Industries, Inc, North… | 2024 |
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 35 years and passes through 11 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 81 ancestors have a recall of any class.
- 2 other devices also cite its predicate K212866.
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?
truFlex 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 arms, buttocks, thighs, and calves * Relaxation of muscle spasms * Prevention or retardation of disuse atrophy * Increasing local blood circulation * Muscle re-education * Maintaining or increasing range of motion * Immediate post-surgical stimulation of calf muscles to…
Read the full statement (107 words)
truFlex 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 arms, buttocks, thighs, and calves
* Relaxation of muscle spasms
* Prevention or retardation of disuse atrophy
* Increasing local blood circulation
* Muscle re-education
* Maintaining or increasing range of motion
* Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
* Stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes
* To be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251594: truFlex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251594
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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