Preparing 510k Submissions for Medical Exercise Equipment
This guidance outlines the requirements for preparing 510(k) premarket notifications for exercise equipment intended for medical purposes, such as muscle redevelopment, joint motion restoration, or obesity treatment adjunct. It specifically covers devices classified under 21 CFR 890.1925, 890.5360, 890.5380, and 890.5410.
Recommended Actions
- Prepare comprehensive device description including all technical specifications and configurations
- Conduct and document performance testing for all measuring functions
- Develop complete hazards analysis for both device and software
- Prepare software documentation according to level of concern
- Ensure safety features implementation and testing (safety switch, ground leakage current)
- Create comprehensive labeling package including all required elements
- Document substantial equivalence to predicate device
- Verify compliance with applicable safety standards
- Prepare 510(k) summary or statement
- Include truthful and accurate statement as required by 21 CFR 807.87(j)
Key Considerations
Non-clinical testing
- Performance data must be provided for all clinical measuring functions
- Testing methodology and conclusions must be described
- Ground leakage current must be less than 100 microamperes for electrical components
- Fire-retarding properties testing for flammable materials
Human Factors
- Safety switch must be clearly identified and easily accessible to the user (for powered devices)
Software
- Documentation requirements based on level of concern
- System and Software Requirements & Design
- Software Development documentation
- Verification & Validation documentation
- Test Results and Analysis
- Certification
- Hazards analysis for software safety requirements
Labelling
- Draft or sample package labeling
- Package inserts
- Complete operator’s and maintenance instructions
- Copies of promotional materials
- Prescription statement if required
- Clear identification of intended motions, muscles, and joints
Safety
- Hazards analysis identifying safety features
- Compliance with electrical and mechanical safety standards
- Ground leakage current specifications
- Safety switch requirements for powered devices
- Fire safety requirements for flammable materials
Other considerations
- Device description including mechanical, electrical, and materials considerations
- Engineering drawings and/or photographs
- Range of motion and force specifications
- Materials identification and processing information
- Substantial equivalence documentation
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
Related references and norms
- IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Original guidance
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