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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
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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