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U.S. Department of Health and Human Services

Product Classification

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Device tens for sinus pain
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Definition Electrical stimulation to relieve pain
Physical State Electrical stimulation unit with electrodes
Technical Method Applies a transcutaneous electrical stimulation with electrodes on the skin.
Target Area Sinuses around nose and forehead
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeQFD
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5890
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