POCKET TENS (EP-300)

The Pocket Tens (EP-300) is a self-adhesive, battery-powered transcutaneous electrical nerve stimulator (TENS) device designed for temporary pain relief in the shoulder, back, upper arms, and legs due to strain from exercise or household work. It features 15 adjustable intensity levels, delivers a 20-minute treatment session, and comes with electrode gel pads and a pocket storage rack.

The device uses a CR2032 3V lithium battery and generates biphasic symmetrical pulses at frequencies of 4, 6, and 50 Hz with a 50 microsecond pulse width. It delivers regulated voltage output with a maximum of 50V peak-to-peak at 500 ohms. Key differences from predicate K171803 include single output channel versus two channels, one TENS mode versus 15 modes, and different power source (3V lithium vs. 4.5V AAA batteries).

Biocompatibility testing per ISO 10993 series (cytotoxicity, skin sensitization, skin irritation); software validation per IEC 62304 and ISO 14971; electromagnetic compatibility and electrical safety per IEC 60601-1-2, IEC 60601-2-10, and ANSI/AAMI ES60601-1; usability per IEC 60601-1-6 and ANSI/AAMI/IEC 62366-1; and battery safety per IEC 60086-4.

Although the subject device has different output modes and channel configuration from predicate K171803, its application area (shoulder, back, upper/lower extremities) falls within the predicate's scope. The output specifications, while numerically different, fall within the parameters of the two predicates and comply with the same electrical safety standards (IEC 60601-2-10 and ANSI/AAMI ES60601-1). Weight and dimensional differences do not raise safety or effectiveness concerns. All devices are electrical stimulation products with the same intended use, making the subject device substantially equivalent in safety and effectiveness.