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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, electrical, transcutaneous, for arthritis
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Definition Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).
Physical State Electrical stimulation unit with leads and cutaneous electrodes.
Technical Method Applies an electrical current through electrodes on patient's skin.
Target Area Over or in proximity to affected joint.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeNYN
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 882.5890
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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