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Premarket Notification Requirements for Manual and Powered Wheelchairs and Three-Wheeled Vehicles

This guidance document outlines the requirements for preparing 510(k) premarket notifications for mechanical wheelchairs, powered wheelchairs, and motorized three-wheeled vehicles. It covers devices classified under 21 CFR 890.3850, 890.3860, 890.3880, 890.3890, 890.3900, and 890.380.

  1. Prepare detailed device description with all required technical specifications and engineering diagrams
  2. Conduct and document all required safety tests (tiltover, electrical, flame retardant)
  3. Develop comprehensive software documentation if device uses controlling software
  4. Prepare EMC compatibility testing documentation for powered devices
  5. Create complete labeling package including EMI requirements
  6. Document substantial equivalence comparison with predicate device
  7. Prepare 510(k) summary or statement
  8. Include truth and accuracy statement
  9. Ensure all dimensional and performance specifications are clearly documented
  10. Verify compliance with all applicable standards and safety requirements

Key Considerations

Non-clinical testing

  • Tiltover tests (lateral, posterior, anterior) with maximum allowable weight and seat height
  • Material strength tests on frame and wheels
  • Flame retardant tests for upholstery materials
  • For powered devices: electrical safety tests for battery recharger
  • For powered devices: ground leakage values (max 100 μA allowed)

Human Factors

  • Maximum weight bearing capacity must be specified
  • Maximum safe operational incline specifications
  • Turning radius specifications
  • Speed limits for powered devices (max 6 m.p.h. allowed)

Software

  • System and Software Requirements & Design documentation
  • Software Development documentation
  • Verification & Validation documentation
  • Test Results and Analysis
  • Certification
  • Hazards analysis identifying safety requirements

Labelling

  • Draft or sample package labeling
  • Package inserts with complete operator’s instructions
  • EMI labeling requirements
  • Prescription statement according to 21 CFR 801.109
  • Promotional materials
  • Cleaning instructions

Safety

  • Breaking system details for powered devices
  • Electrical safety requirements
  • EMC compatibility requirements
  • Battery specifications and travel distance

Other considerations

  • ISO 7176-14: Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
  • ANSI/RESNA standards (referenced but not specified)

Original guidance

  • Premarket Notification Requirements for Manual and Powered Wheelchairs and Three-Wheeled Vehicles
  • HTML / PDF
  • Issue date: 1995-07-25
  • Last changed date: 2020-03-17
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket
  • ReguVirta summary file ID: d5da8d8d54e65d02c5eaa090fabcd802
This post is licensed under CC BY 4.0 by the author.