CP Relief Wand Rx - TENS/NMES

The CP Relief Wand Rx - TENS/NMES is a portable, battery-powered device that combines transcutaneous electrical nerve stimulation (TENS) and electrical muscular stimulation (EMS) for pain management and muscle therapy. As a TENS device, it provides symptomatic relief of chronic intractable pain and acute post-surgical/post-traumatic pain. As an EMS device, it relaxes muscle spasm, increases blood circulation, aids muscle re-education, prevents disuse atrophy, and maintains range of motion.

The device is portable with self-contained electrodes powered by a 9-volt alkaline battery. It features adjustable intensity (0-8 dial), selectable pulse width (150 or 230 microseconds), polarity switching, and continuous treatment capability. The waveform is biphasic rectangular with fixed 40 Hz frequency, maximum output voltage of 81.5V at 2K ohms, and maximum output current of 40.75 mA at 2K ohms. It uses Spectra 360 electrode gel and has no microprocessor control or rechargeable battery, unlike some predicate comparators.

IEC60601-1 Edition 2:1988 (A1:1991 + A2:1995) for medical electrical equipment general safety and essential performance; IEC60601-1-2:2007 Third Edition for electromagnetic compatibility; and IEC60601-2-10 (1987) and Amendment 1 (2001) for nerve and muscle stimulator safety and essential performance.

The device is technologically identical to the primary predicate (CP Relief Wand Model CP-1000, K133779) in all design features except the addition of EMS capability and gel electrode media. For the new EMS indication, the waveform attributes—particularly the biphasic rectangular waveform, pulse width range, frequency, maximum output voltage, current, and power density—are substantially equivalent to the second predicate (Unipro TENS/EMS combination device, K232441). Since the devices share near-identical principles of operation (surface application to intact skin), and the expanded EMS indication matches established predicate specifications for that modality, the differences do not raise new safety or effectiveness questions.