Stroller, Adaptive

Device Code: 5214

Product Code(s): LBE

Device Classification Information

Device Type ID	5214
Device Name	Stroller, Adaptive
Regulation Description	Mechanical Wheelchair.
Regulation Medical Specialty	Physical Medicine
Review Panel	Physical Medicine
Premarket Review	Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB)
Submission Type	510(k)
CFR Regulation Number	890.3850 [🔎]
FDA Device Classification	Class 1 Medical Device
Product Code	LBE
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Eligible For Accredited Persons Program

Recognized 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
16-168 ANSI RESNA WC-1:2009 (2009-10-02) Section 1 Determination Of Static Stability
American National Standard For Wheelchairs - Volume 1: Requirements And Test Methods For Wheelchairs (including Scooters) Section 1 Determination Of Static Stability
16-170 ANSI RESNA WC-2:2009 Section 3: Determination Of Effectiveness Of Brakes
American National Standard For Wheelchairs - Volume 2: Additional Requirements For Wheelchairs (including Scooters) With Electrical Systems Section 3: Determination Of Effectiveness Of Brakes
16-172 ANSI RESNA WC-1:2009 Section 5: Determination Of Dimensions, Mass And Maneuvering Space
American National Standard For Wheelchairs - Volume 1: Requirements And Test Methods For Wheelchairs (including Scooters) Section 5: Determination Of Dimensions, Mass And Maneuvering Space
16-174 ANSI RESNA WC-1:2009 Section 7: Method Of Measurement Of Seating And Wheel Dimensions
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
16-175 ANSI RESNA WC-1:2009 Section 8: Requirements And Test Methods For Static, Impact And Fatigue Strengths
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
16-178 ANSI RESNA WC-1:2009
American National Standard For Wheelchairs - Volume 1: Requirements And Test Methods For Wheelchairs (including Scooters) Section 11: Test Dummies
16-179 ANSI RESNA WC-1:2009 Section 13: Determination Of Coefficient Of Friction Of Test Surfaces
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
16-181 ANSI RESNA WC-1:2009 Section 15: Requirements For Information Disclosure, Documentation And Labeling
American National Standard For Wheelchairs - Volume 1: Requirements And Test Methods For Wheelchairs (including Scooters) Section 15: Requirements For Information Disclosure, Documentation And Labeling
16-182 ANSI RESNA WC-1:2009 Section 16: Resistance To Ignition Of Upholstered Parts - Requirements And Test Methods
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
16-184 ANSI RESNA WC-1:2009 Section 22: Set-up Procedures
American National Standard For Wheelchairs - Volume 1: Requirements And Test Methods For Wheels Chairs (including Scooters) Section 22: Set-up Procedures
16-187 ANSI RESNA WC-1:2009 Section 26: Vocabulary
American National Standard For Wheelchairs - Volume 1: Requirements And Test Methods For Wheelchairs (including Scooters) Section 26: Vocabulary
16-190 ISO 7176-11 Second Edition 2012-12-01
Wheelchairs - Part 11: Test Dummies
16-191 ISO 7176-16 Second Edition 2012-12-01
Wheelchairs - Part 16: Resistance To Ignition Of Postural Support Devices
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)]
16-205 RESNA WC-4:2017
RESNA Standard For Wheelchairs Volume 4: Wheelchairs And Transportation.

Total Product Life Cycle

Device Type ID	5214
Device	Stroller, Adaptive
Product Code	LBE
FDA Device Classification	Class 1 Medical Device
Regulation Description	Mechanical Wheelchair.
CFR Regulation Number	890.3850 [🔎]

TPLC Last Update: 2019-04-02 21:02:14