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.
What You Need to Know? 👇
What are the key regulatory classifications for exercise equipment under FDA 510(k) requirements?
Exercise equipment falls under Class II regulations including 21 CFR 890.1925 (Isokinetic Testing), 890.5360 (Measuring Exercise Equipment), 890.5380 (Powered Exercise Equipment), and 890.5410 (Powered Finger Exerciser), each requiring specific documentation for substantial equivalence determination.
When is exercise equipment exempt from FDA 510(k) premarket notification requirements?
Exercise equipment classified under 21 CFR 890.5350 (Exercise Component) and 890.5370 (Nonmeasuring Exercise Equipment) are Class I devices exempt from 510(k) requirements. However, they remain subject to general controls and FDA oversight.
What software documentation is required for exercise equipment with controlling software in 510(k) submissions?
Software documentation must include system requirements, development processes, verification and validation procedures, test results, certification, and hazards analysis. The level of documentation should be commensurate with the software’s level of concern for patient safety.
What safety requirements must be addressed for powered exercise equipment in 510(k) applications?
Powered exercise equipment must include safety switches easily accessible to users, ground leakage current specifications (less than 100 microamperes), hazards analysis, fire-retarding material testing, and compliance with applicable electrical and mechanical safety standards.
How does FDA distinguish between medical and non-medical exercise equipment for regulatory purposes?
FDA only regulates exercise equipment intended for medical purposes such as muscle redevelopment, joint motion restoration, or obesity treatment. Equipment intended solely for general physical conditioning or athletic development in non-impaired individuals is not regulated.
What predicate device information is essential for demonstrating substantial equivalence in exercise equipment 510(k) submissions?
Submissions must identify legally marketed predicate devices with 510(k) numbers or pre-1976 commercial evidence, provide comparative tables showing similarities and differences in intended use, functions, and physical characteristics, plus written substantial equivalence summaries.
What You Need to Do 👇
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