Bioelectronics Corp (BIEL)

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FDA-Device-ACTIPATCH-Nonthermal-Shortwave-Therapy-Device-Indicated-For-Over-The-Counter Use For The Treatment Of Pain

Regulation Description Shortwave diathermy.

Definition Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain.

Physical State Nonthermal shortwave therapy devices which include applicators applied to the body.

Technical Method Uses pulsed electromagnetic energy at 13.56 MHz or 27.12 MHz delivered treatment.

Target Area To be applied over body areas and joints such as the knee and ankle; however, the device should not be applied directly over areas with active implantables.