VEINOPLUS Back

The VEINOPLUS Back is a non-invasive, battery-operated over-the-counter device that provides transcutaneous electrical nerve stimulation (TENS) for temporary pain relief. It consists of a handheld device with LCD screen, self-adhesive electrodes, connecting cable, and 9V battery. The device is designed specifically for pain associated with sore and aching muscles in the back (shoulder, middle back, or lumbar area) due to strain from exercise or normal household and work activities.

The subject device operates using the same TENS mechanism of action as the predicate with similar form factor (handheld unit, self-adhesive electrodes, battery power, user controls, and safety features). Key differences include: monophasic rectangular asymmetric waveform versus biphasic square; voltage regulation versus current regulation; maximum output voltage of 50±5V at 500Ω versus 96±20V; frequency range 1-120 Hz versus 1-150 Hz; and pulse width 25-240 microseconds versus 50-300 microseconds. Despite these differences, specifications remain within the predicate's range.

Electrical safety and performance testing was completed in accordance with IEC 60601-1 (general requirements), IEC 60601-1-2 (electromagnetic compatibility), and IEC 60601-2-10 (particular standards for nerve stimulators).

The subject device is substantially equivalent because it has the same intended use (TENS for temporary pain relief) and operates through the same mechanism of action as the predicate device. Although technical output specifications differ (waveform, frequency, voltage, pulse width), these differences are within the predicate's operating range and raise no different questions of safety or effectiveness. Testing demonstrated compliance with applicable safety and performance standards matching the predicate device.