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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, nerve, electrical, transcutaneous, limited output, arthritis pain relief
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Definition Electrical stimulation of nerves for relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).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 a patient's skin.
Target Area Electrodes are placed on the skin to stimulate nerves in proximity to the painful joint.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeOCF
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurostimulation Devices Branch (NSDB)
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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