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.
Recommended Actions
- Prepare detailed device description with all required technical specifications and engineering diagrams
- Conduct and document all required safety tests (tiltover, electrical, flame retardant)
- Develop comprehensive software documentation if device uses controlling software
- Prepare EMC compatibility testing documentation for powered devices
- Create complete labeling package including EMI requirements
- Document substantial equivalence comparison with predicate device
- Prepare 510(k) summary or statement
- Include truth and accuracy statement
- Ensure all dimensional and performance specifications are clearly documented
- 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
- Device description including dimensions and components
- Engineering diagrams and photographs
- Materials identification and specifications
- Surface operation specifications
- Substantial equivalence information
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Electromagnetic Compatibility for Medical Devices and Accessories: Testing, Documentation, and Labeling Requirements
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms
- 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
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