The OW100S is indicated to provide acoustic pressure shockwave in the treatment of chronic, full-thickness diabetic foot ulcer with wound area measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 year and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care. The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 year or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).
An assembly of devices designed to provide spark-gap-generated extracorporeal shock wave therapy (ESWT) intended to treat acute and chronic conditions of the skin and subcutaneous soft tissues (e.g., arterial, venous, diabetic or pressure ulcers; burns; postoperative or traumatic wounds; cellulite). It typically consists of a generator that supplies the high voltage energy; and a hand-held, fluid-filled, shock wave applicator that produces spark-gap (electrohydraulic) energy delivered non-invasively to the area of the skin in contact with the applicator. Treatment parameters are intended to be input manually or from a pre-programmed radio-frequency identification (RFID) card.
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