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U.S. Department of Health and Human Services

Product Classification

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Device transport, patient, powered
Regulation Description Powered patient transport.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeILK
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 890.5150
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment - Guidance for Industry and FDA Staff
Third Party Review
Accredited Persons

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