It's a range in the product classification code Product Classification Print Share E-mail FDA HomeMedical DevicesDatabases - New Search Back to Search Results Device 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. Regulation Medical Specialty Physical Medicine Review Panel Physical Medicine Product Code PQY Premarket Review Office of Device Evaluation (ODE) Division of Neurological and Physical Medicine Devices (DNPMD) Physical Medicine and Rehabilitation Devices Branch (PMDB) Submission Type 510(k) Regulation Number 890.5290 Device Class 2 Total Product Life Cycle (TPLC) TPLC Product Code Report GMP Exempt? No Summary Malfunction Reporting Ineligible Implanted Device? No Life-Sustain/Support Device? No Third Party Review Not Third Party Eligible - - Page Last Updated: 10/29/2018