Product Classification

• 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 Neurological and Physical Medicine Devices (OHT5); Neuromodulation and Physical Medicine Devices (DHT5B)
• 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