Product Classification

• Device: stroller, adaptive
• Regulation Description: Mechanical wheelchair.
• Regulation Medical Specialty: Physical Medicine
• Review Panel: Physical Medicine
• Product Code: LBE
• Premarket Review: Neuromodulation and Physical Medicine Devices (DHT5B); Neuromodulation and Physical Medicine Devices (DHT5B)
• Submission Type: 510(k)
• Regulation Number: 890.3850
• Device Class: 1
• 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
• 16-163 ISO 7176-5 Second edition 2008-06-01
  Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
• 16-190 ISO 7176-11 Second edition 2012-12-01
  Wheelchairs - Part 11: Test dummies
• 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
• 16-201 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)]
• 16-207 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
• 16-209 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
• 16-211 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
• 16-213 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
• 16-217 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
• 16-220 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
• 16-225 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
• 16-233 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
• 16-236 ISO 7176-19 Third Edition 2022
  Wheelchairs - Part 19: Wheeled mobility devices for use as seats in motor vehicles

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc