Sofwave Medical LTD
Open-label, non-randomized, prospective, single-center, self-controlled clinical study.
Eligible subjects will be divided into two groups. The test group will include 15-22 subjects who will be treated to revive their body's functional potential, and the control group will include 15-22 subjects, who will not be treated. The Test group will arrive to 6 Pure Impact sessions and to 4 weeks follow-up visit; while the control group will arrive to 3 visits, which are equivalent to before first treatment, last treatment (5 weeks after first visit) and 4 weeks after the second visit (equivalent to 4 weeks follow-up visit of the test group). Subjects of the test group will receive 6 Pu…
Inclusion Criteria: 1. Male or female subjects ≥ 25 years of age and ≤ 60 years of age. 2. Not pregnant or lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide) or abstinence. 3. Desire to undergo treatments on abdomen and quadriceps and/or on hamstring and glutes for strength and tone muscles. 4. Subject agrees to maintain their weight within 5% of total body weight and avoid significant dietary or exerc…
Pure Impact is an EMS module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated.
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