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U.S. Department of Health and Human Services

Product Classification

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Device nonthermal shortwave therapy device indicated for over the counter use for the treatment of pain
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 CodePQY
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible