Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)

The Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, LGT-2320SP) is a non-invasive electrotherapy device that delivers neuromuscular electrical stimulation (NMES) to stimulate healthy muscles for improved performance, and transcutaneous electrical nerve stimulation (TENS) for temporary pain relief from sore/aching muscles and chronic/arthritic pain. The device consists of a main unit, hand switch, and electrode pads powered by AC mains (100–240 V).

The subject device features 3 channel groups delivering NMES and TENS current with pulse frequencies of 1–120 Hz, pulse durations of 80–400 μs (NMES: 200–400 μs; TENS: 70–300 μs), multiple output modes (Normal, Sweep, Random, Alternate), rectangular biphasic waveforms, and automatic overload protection. It differs from the predicate (Compex Sport Elite 3.0) primarily in having AC power instead of rechargeable battery, 3 channels vs. 4, additional output modes, and slightly different electrical specifications (e.g., 54.4 V @ 500 Ω vs. 60 V ± 10%).

Testing was performed per IEC 60601-1:2020 (electrical safety and essential performance), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-2-10:2016 (nerve and muscle stimulator safety), IEC 60601-1-6:2020 (usability), ISO 10993-10:2010 (skin irritation and sensitization), and ISO 10993-5:2009 (in vitro cytotoxicity). Performance testing included waveform verification, accelerated aging, and software verification.

The subject device is substantially equivalent to the Compex Sport Elite 3.0 predicate because both are Class II powered muscle stimulators with identical intended uses (NMES for muscle conditioning and TENS for pain relief), similar non-invasive external applications, comparable electrical operating principles, and matching safety features (automatic overload trip, user override, On/Off controls). Differences in device dimensions, power source, number of channels, and output modes do not raise new safety or effectiveness issues, as the device meets the same regulatory standards and demonstrates equivalent performance through rigorous testing.