Compact II

The Compact II is a powered muscle stimulator that uses magnetic fields to generate electrical currents in targeted tissues for therapeutic treatment. It is indicated for muscle spasm relaxation, prevention of disuse atrophy, increased blood circulation, muscle re-education, post-surgical calf muscle stimulation to prevent blood clots, and maintaining or increasing range of motion.

The Compact II has one magnetic coil applicator with field intensity of 1.0–2.5 T, pulse repetition rate of 1–100 Hz (±20%), pulse duration of 420 µs (±20%), and maximum therapy time of 60 minutes. It operates on 220–240 V~, 50–60 Hz power, weighs approximately 23 kg, and has dimensions of 440 × 200 × 338 mm. The predicate device (Talent-Pro) has two applicators, higher pulse repetition rate (1–150 Hz), different pulse duration (280 µs), different power requirements (120 V~, 60 Hz), weighs 60 kg, and has larger dimensions (542 × 501 × 1073 mm).

IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic disturbance), IEC TS 60601-4-2 (electromagnetic immunity), IEC 62304 (software life cycle), ISO 14971 (risk management), ISO 10993-1 and 10993-5 and 10993-10 (biocompatibility), and IEC 62366 (usability engineering).

The Compact II shares identical primary function (muscle stimulation), electrical protection class, user interface type, energy type (magnetic field), coil count, field intensity, operation type, pulse shape, and maximum therapy time as the predicate. Differences in applicator count (1 vs. 2), pulse repetition rate, pulse duration, power source, dimensions, weight, and operating conditions do not raise new safety or effectiveness questions because: users operate one applicator at a time regardless; pulse repetition rate is user-settable and the lower maximum (100 Hz vs. 150 Hz) is clinically acceptable; pulse duration differences (420 vs. 280 µs) remain within typical clinical range (50–500 µs); power and dimensional differences reflect regional standards and form factor only; and all electrical safety testing confirms compliance with IEC 60601-1.