Product Classification [proxy]

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Device	stimulator, nerve, transcutaneous, over-the-counter
Regulation Description	Transcutaneous electrical nerve stimulator for pain relief.
Definition	TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
Regulation Medical Specialty	Neurology
Review Panel	Neurology
Product Code	NUH
Premarket Review	Office of Neurological and Physical Medicine Devices (OHT5) Neuromodulation and Physical Medicine 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 Reporting	Eligible
Implanted Device?	No
Life-Sustain/Support Device?	No
Recognized Consensus Standard 17-22 IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Third Party Review Eligible for 510(k) Third Party Review Program
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