CDRH UNTITLED LETTERS: 7700W.Dynatronics, Salt Lake City, UT, Aug. 20, 1998 (CDRH-OC). In response to FDA's July 1998 request, the com-pany submitted promotional materials for the Synergie Aesthetic Massage massage (məsäzh`), treatment of superficial parts of the body by systematic rubbing, stroking, kneading, or slapping. Massages can be administered manually or with mechanical devices. System. After reviewing these and a press release published by Reuters, FDA FDAabbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. said claims for therapeutic massagers related to weight reduction, cellulite cel·lu·lite n. A fatty deposit causing a dimpled or uneven appearance, as around the thighs. Cellulite Cellulite is dimply skin caused by uneven fat deposits beneath the surface. reduc-tion and dimensional changes constituted significant modifications requiring a 510(k). The agency explained that therapeutic massagers are exempt from 510(k) requirements only if claims are restricted to temporary increase in local blood circulation and local muscle relaxation re·lax·a·tion n. 1. The act of relaxing or the state of being relaxed. 2. Refreshment of body or mind. 3. A loosening or slackening. 4. The lengthening of inactive muscle or muscle fibers. . 510(k) |
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