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U.S. Department of Health and Human Services

Product Classification

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Device wheelchair, stair climbing
Regulation Description Stair-climbing wheelchair.
Definition Pma to be filed by 7/12/00 (65 fr 19834 (4/13/00)).
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeIMK
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type PMA
Regulation Number 890.3890
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles
Third Party Review Not Third Party Eligible
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