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Products >> FDA 510k Submission for Electric Wheelchair
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FDA 510k Submission for Electric Wheelchair
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FDA 510(k) Submission for Electric Wheelchair: Key Considerations
1. Introduction
The U.S. Food and Drug Administration (FDA) requires manufacturers to submit a 510(k) premarket notification for electric wheelchairs classified as Class II medical devices (Product Code: ISOQ). This ***ument outlines the critical steps and components for a successful submission, demonstrating substantial equivalence (SE) to a legally marketed predicate device.
2. Predicate Device Identification
? Example Predicate: "ABC Mobility Model XYZ" (K123456), an FDA-cleared electric wheelchair with similar intended use, technological characteristics, and safety profile.
? Justification for SE must address:
Intended use (e.g., mobility assistance for individuals with disabilities).
Technical specifications (speed, weight capacity, battery life, etc.).
3. Device Description
Provide ***ailed information about your electric wheelchair, including:
? Design: Frame material, dimensions, seating system, control mechanism (joystick/sip-and-puff).
? Technical Parameters: Maximum speed (typically ¡Ü6 mph per FDA guidance), range per charge, safety features (e.g., anti-tip wheels, braking system).
? Labeling: Proposed user manual, warnings, and contraindications.
4. Performance Testing & Data
? Safety Standards Compliance:
IEC 60601-1 (Electrical Safety)
ISO 7176-series (Wheelchair Performance & Durability)
FDA¡¯s Electromagnetic Co***tibility (EMC) requirements.
? Testing Reports: Include results for:
Battery safety (overcharge/overheating protection).
Stability testing (static/dynamic tilt tests).
Software validation (if applicable).
5. Bioco***tibility & Risk Analysis
? ISO 10993-1: Assess skin-contact components (seat cushions, armrests) for cytotoxicity/sensitization.
? Risk Management (ISO 14971): ***ument hazards (e.g., unintended motion, battery leakage) and mitigation strategies.
6. Clinical Evidence (if needed)
While most 510(k)s for electric wheelchairs rely on non-clinical data, any novel |
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