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EMS is used for: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion - Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis TENS is used for: - Symptomatic relief and management of chronic, intractable pain - Post-surgical acute pain - Post-trauma acute pain

EVE Synergy has Synergy handpiece (1EA), Pro handpiece (2EA), Micro cable, Tip (Ball type, T type, COMB type) and Power adaptor & cable. EVE Synergy has Synergy mode and Pro mode. Synergy mode has radio frequency and low frequency functions using a synergy handpiece. The Synergy handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43℃. Pro mode has low frequency function that uses the Pro handpiece with tip. It should be noted that the device has radio frequency (RF Mode) indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. This RF mode was previously reviewed by the FDA under K212253 and was cleared under regulation 21 CFR 878.4400 (Product code PBX). In the subject submission, there are no changes being proposed related to the RF Mode, and, hence, the review of the RF Mode is not within the scope of the subject 510(k) submission.

EMS is used for: - · Relaxation of muscle spasms - · Prevention or retardation of disuse atrophy - · Increasing local blood circulation - · Muscle re-education - · Maintaining or increasing range of motion - · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

eMVFit has MULTI handpiece, EMS handpiece, patient switch, cradle, distilled water injection hose & funnel, key switch and power cable. eMVFit has a user interface including an LCD touch screen and has MULTI mode and EMS mode. MULTI mode has RF and EMS functions that use the MULTI handpiece. In the case of RF, the target temperature can be set and a vacuum can be used together, and a cooling function can be used as a safety system to prevent burns on the skin surface. In addition, the MULTI handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43 ℃. EMS mode has an EMS function that uses the EMS handpiece.