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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, muscle, powered, dental
Regulation Description Powered muscle stimulator.
Definition Relief of muscle spasms associated with tmj.Muscle reeducation, increasing blood flow.
Regulation Medical Specialty Physical Medicine
Review Panel Dental
Product CodeNUW
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 890.5850
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons