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U.S. Department of Health and Human Services

Product Classification

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Device wheelchair, standup
Regulation Description Standup wheelchair.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeIPL
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 890.3900
Device Class 2
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
Accredited Persons

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