| K-number | K251594 |
| Device name | truFlex |
| Applicant | Syrma Johari Medtech Limited |
| Product code | NGX |
| Device class | Class II |
| Decision date | Aug 28, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 890.5850 |
truFlex is an electrical muscle stimulator that generates electrical impulses delivered through electrodes to contract muscles rhythmically. It is indicated for muscle strengthening, toning, and firming of the abdomen, arms, buttocks, thighs, and calves; relaxation of muscle spasms; prevention of disuse atrophy; blood circulation improvement; muscle re-education; range of motion maintenance; post-surgical calf muscle stimulation to prevent thrombosis; and neuromuscular tissue stimulation for rehabilitative purposes and adjunctive therapy for medical conditions.
truFlex is identical to predicate device truSculpt Flex (K212866) in fundamental specifications: same power source (100-240AC, 50/60Hz, 75VA), same therapeutic modality (electrical muscle stimulation via electrode), same three output modes (PREP, TONE, SCULPT), same waveform (symmetrical biphasic), identical output voltage and current specifications, same isolation method (2XMOPP via medical-grade PSU), same patient leakage limits, and identical timer ranges (15, 30, 45 minutes). Device specifications match or fall within acceptable limits compared to predicate devices per guidance documents and ANSI/AAMI NS4:2013 standards.
ISO 14971:2019 (risk management), IEC 60601-1:2005+AMD:2012 (medical electrical equipment safety), IEC 60601-1-2:2014 (electromagnetic compatibility), IEC 60601-2-10 (nerve and muscle stimulator requirements), IEC 60601-1-6:2020 (usability), IEC 62304:2015 (software lifecycle), ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021 (biological evaluation), and IEC TR 60601-4-2 (electromagnetic immunity).
The only modification to truFlex is an expanded indication for use, which is entirely derived from and already covered by three FDA-cleared predicate devices (truSculpt Flex K212866, Accufit K233926, emSculpt NEO K240234). There are no changes to fundamental scientific principles, performance specifications, operation, or technological design. The device maintains identical electrical and safety characteristics to its primary predicate (truSculpt Flex), with minor performance deviations remaining within acceptable limits per established guidance and industry standards. Therefore, the device presents no new safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov