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Product Classification

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Device

wheelchair, mechanical

Regulation Description

Mechanical wheelchair.

Definition

A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and/or require an assistive device for mobility.

Regulation Medical Specialty

Physical Medicine

Review Panel

Physical Medicine

Product Code

IOR

Premarket Review

Office of Neurological and Physical Medicine Devices (OHT5)
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
16-162 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
16-166 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
16-195 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
16-202 ISO 7176-2 Third edition 2017-10
Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs
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
16-209 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
16-234 ISO 7176-14 Third Edition 2022
Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
16-236 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

Eligible for 510(k) Third Party Review Program

Accredited Persons

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