Muscle Stimulator Device (PZ-100)

The Muscle Stimulator Device (PZ-100) is a non-invasive therapeutic device that produces electromagnetic fields to stimulate muscles. It is indicated for improvement of abdominal tone and muscle strengthening, toning and firming of buttocks, thighs, calves, and arms. The device features a touch screen interface and can apply multiple treatment handles simultaneously, held in place by bandages.

The proposed device has four outputs compared to the predicate's two outputs, and is Class I electrical protection versus the predicate's Class II. Both use magnetic field energy with similar field intensities (0.5-1.8 T and 0.7-2.0 T ranges), identical pulse repetition rates (1-150 Hz), and comparable pulse durations around 280 microseconds. Minor differences exist in applicator dimensions, system dimensions, ambient temperature range, and energy source specifications.

IEC 60601-1:2020, IEC 60601-1-2:2020, IEC 60601-2-10:2016, IEC 60601-1-6:2020 (medical electrical equipment safety), ISO 10993-5:2009, ISO 10993-10:2021, and ISO 10993-23:2021 (biocompatibility testing for cytotoxicity, skin sensitization, and irritation).

The device is substantially equivalent because it uses the same principle of action (initiating muscle contraction via nerve stimulation), has identical indications for use, applies the same type of magnetic field energy with comparable intensities and pulse parameters, and meets all the same safety and performance standards. The differences (4 outputs vs. 2, Class I vs. Class II electrical protection, minor dimensional variations) do not raise new safety or effectiveness questions because both devices comply with the same IEC standards and the increased number of outputs does not fundamentally change the mechanism or risk profile.