Product Classification

• Device: wheelchair, mechanical
• Regulation Description: Mechanical wheelchair.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Product Code: IOR
• Submission Type: 510(k)
• Regulation Number: 890.3850
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 7176-11:1992 Wheelchairs - Part 11: Test dummies
• ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
• ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labelling
• ISO 7176-16:1997 Wheelchairs - Part 16: Resistance to ignition of upholstered parts -- Requirements and test methods
• ISO 7176-6:2001 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
• ISO 7176-3:2003 Wheelchairs - Part 3: Determination of effectiveness of brakes
• ISO 7176-1:1999 Wheelchairs - Part 1: Determination of static stability
• ISO 7176-2:2001 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
• ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
• ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
• ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
• ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
• ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
• ISO 7176-9: Third edition 2009-11-15 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
• ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1 Determination of static stability
• ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space
• ANSI/RESNA
• ANSI/RESNA
• ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs ¿ Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of Measurement of Seating and Wheel Dimensions
• ANSI/RESNA
• ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, impact and fatigue strengths
• ANSI/RESNA
• ANSI/RESNA
• ANSI/RESNA
• ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummies
• ANSI/RESNA
• ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of coefficient of friction of test surfaces
• ANSI/RESNA
• ANSI/RESNA
• ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for information disclosure, documentation and labeling
• ANSI/RESNA
• ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to ignition of upholstered parts - Requirements and test methods
• ANSI/RESNA
• ANSI/RESNA
• ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelschairs (including Scooters) Section 22: Set-up procedures
• ANSI/RESNA
• ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary
• A18.1-2011 (Revision of ASME A18.1-2008) Safety Standard for Platform Lifts and Stairway Chairlifts

Guidance Document

• Guidance Document for the Preparation of Premarket Notification [510k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.