BTL-785MJ

The BTL-785MJ is an electrostimulation device used to relieve muscle spasm symptoms, treat temporomandibular joint (TMJ) dysfunction and pain, support muscle re-education, increase blood flow, and maintain or increase mandibular range of motion. It consists of a main control unit with a color touchscreen, handpiece, holding arm, connection cables, and single-use applicator pads that deliver electrical stimulation therapy.

The BTL-785MJ uses similar electrical stimulation technology with comparable output parameters to the predicate device: preset pulse widths (up to 150 μs and 488 μs), output frequencies (up to 200 Hz and 0.67 Hz), output currents (up to 80 mA), and therapy duration (20–60 minutes). Both devices use rectangular pulse shapes, pad-type single-use applicators with conductive ink and hydrogel, and operate at the same electrical safety class (Class II, BF) with identical voltage ranges (100–120 V AC and 200–240 V AC, 50/60 Hz).

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-6, IEC 62304, ISO 14971, ISO 10993-1, ISO 10993-5, and ISO 10993-10. The device complies with medical electrical equipment safety and biocompatibility standards for nerve and muscle stimulators.

The BTL-785MJ shares the same therapeutic principle of action (electrical stimulation), identical indications for use, matching prescription-use classification, and substantially similar electrical and mechanical specifications compared to the predicate device (D function, K203525). Any differences in system weight and dimensions have no significant influence on safety or effectiveness because they relate only to device form factor, not the core stimulation technology or clinical performance.