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U.S. Department of Health and Human Services

Product Classification

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Device transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms
Definition Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms.
Physical State Electrical stimulation unit with leads and cutaneous electrodes.
Technical Method Applies an electrical current through electrodes on patient's skin.
Target Area Sensory nerves
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeQSQ
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5888
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
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