Product Classification

• Device: wheelchair, stair climbing
• Regulation Description: Stair-climbing wheelchair.
• Definition: PMA To Be Filed by 7/12/00 (65 FR 19834 (4/13/00))
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Product Code: IMK
• Premarket Review: Office of Neurological and Physical Medicine Devices (OHT5); Neuromodulation and Rehabilitation Devices (DHT5B)
• Submission Type: 510(k)
• Regulation Number: 890.3890
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 16-25 ISO 7176-13 First edition 1989-08-01
  Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
• 16-27 ISO 7176-15 First edition 1996-11-15
  Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
• 16-162 ISO 7176-4 Third edition 2008-10-01
  Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
• 16-163 ISO 7176-5 Second edition 2008-06-01
  Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
• 16-164 ISO 7176-10 Second edition 2008-11-01
  Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
• 16-165 ISO 7176-14 Second edition 2008-02-15
  Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
• 16-166 ISO 7176-21 Second edition 2009-04-01
  Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
• 16-167 ISO 7176-9 Third edition 2009-11-15
  Wheelchairs - Part 9: Climatic tests for electric wheelchairs
• 16-190 ISO 7176-11 Second edition 2012-12-01
  Wheelchairs - Part 11: Test dummies
• 16-192 ISO 7176-3 Third edition 2012-12-15
  Wheelchairs - Part 3: Determination of effectiveness of brakes
• 16-194 ISO 7176-25 First edition 2013-07-15
  Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
• 16-195 ISO 7176-1 Third edition 2014-10-01
  Wheelchairs - Part 1: Determination of static stability
• 16-196 ISO 7176-7 First Edition 1998-05-15
  Wheelchairs - Part 7: Measurement of seating and wheel dimensions
• 16-197 ISO 7176-8 Second editon 2014-12-15
  Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
• 16-198 ISO 7176-22 Second edition 2014-09-01
  Wheelchairs - Part 22: Set-up procedures
• 16-199 ISO 7176-28 First edition 2012-10-1
  Wheelchairs Part 28: Requirements and test methods for stairclimbing devices
• 16-201 ISO 7176-19 Second Edition 2008-07-15
  Wheelchairs Part 19: Wheeled mobility devices for use as seats in motor vehicles [Including AMENDMENT 1 (2015)]
• 16-202 ISO 7176-2 Third edition 2017-10
  Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs
• 16-203 ASME A18.1-2017
  Safety Standard for Platform Lifts and Stairway Chairlifts
• 16-204 ISO 7176-6 Third edition 2018-06
  Wheelchairs - Part 6: Determination of maximum speed of electrically powered wheelchairs
• 16-206 ISO 7176 - 30 First edition 2018-12
  Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements
• 16-207 ANSI RESNA WC-1:2019 Section 1
  American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability
• 16-208 ANSI RESNA WC-2:2019 Section 2
  American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs
• 16-209 ANSI RESNA WC-1:2019 Section 3
  American National Standard for Wheelchairs - Volume 1: Additional Requirements for Wheelchairs (including Scooters) Section 3: Determination of effectiveness of brakes
• 16-210 ANSI RESNA WC-2:2019 Section 4
  American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range
• 16-211 ANSI RESNA WC-1:2019 Section 5
  American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space
• 16-212 ANSI RESNA WC-2:2019 Section 6
  American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed of electrically powered wheelchairs.
• 16-213 ANSI RESNA WC-1:2019 Section 7
  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
• 16-214 ANSI RESNA WC-1:2019 Section 8
  American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, Iipact and fatigue strengths
• 16-215 ANSI RESNA WC-2:2019 Section 9
  American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for Eeectrically powered wheelchairs
• 16-216 ANSI RESNA WC-2:2019 Section 10
  American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
• 16-217 ANSI RESNA WC-1:2019 Section 11
  American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test mannequins
• 16-218 ANSI RESNA WC-1:2019 Section 13
  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
• 16-219 ANSI RESNA WC-2:2019 Section 14
  American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and Control Systems for Electrically Powered Wheelchairs Requirements and Test Methods
• 16-220 ANSI RESNA WC-1:2019 Section 15
  American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for Information Disclosure, Documentation and Labeling
• 16-221 ANSI RESNA WC-1:2019 Section 16
  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
• 16-223 ANSI RESNA WC-1:2019 Section 22
  American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheels chairs (including Scooters) Section 22: Set-up Procedures
• 16-224 ANSI RESNA WC-2:2019 Section 21
  American National Standard for Wheelchairs - Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters
• 16-225 ANSI RESNA WC-1:2019 Section 26
  American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary
• 16-230 ANSI RESNA WC-2:2019 Section 25
  American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries and Chargers for Powered Wheelchairs
• 16-233 ISO 16840-10 Second edition 2021-06 Corrected version 2022-01
  Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method
• 16-234 ISO 7176-14 Third Edition 2022
  Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
• 16-235 ISO 7176-25 Second Edition 2022
  Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods
• 16-236 ISO 7176-19 Third Edition 2022
  Wheelchairs - Part 19: Wheeled mobility devices for use as seats in motor vehicles

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

Not Third Party Eligible