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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, muscle, powered
Regulation Description Powered muscle stimulator.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeIPF
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 890.5850
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Guidance Document
  • Guidance Document for Powered Muscle Stimulator 510(k)s; Final
Third Party Review
Accredited Persons

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