Wheelchair, Standup

Device Code: 5137

Product Code(s): IPL

Device Classification Information

Device Type ID	5137
Device Name	Wheelchair, Standup
Regulation Description	Standup 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	890.3900 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	IPL
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
16-29 ISO 7176-6 Second Edition 2001-10-01
Wheelchairs - Part 6: Determination Of Maximum Speed, Acceleration And Deceleration Of Electric Wheelchairs
16-159 ISO 7176-2 Second Edition 2001-06-15
Wheelchairs - Part 2: Determination Of Dynamic Stability Of Electric Wheelchairs
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
16-168 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
16-169 ANSI RESNA WC-2:2009 Section 2: Determination Of Dynamic Stability Of
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
16-170 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
16-171 ANSI RESNA WC-2:2009 Section 4: Energy Consumption Of Electrically Powered Wheelchairs And Scooters For Determi
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
16-172 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
16-173 ANSI RESNA WC-2:2009 Section 6: Determination Of Maximum Speed, Acceleration And Deceleration Of Electrically P
American National Standard For Wheelchairs - Volume 2: Additional Requirements For Wheelchairs (including Scooters) With Electrical Systems Section 6: Determination Of Maximum Speed, Acceleration And Deceleration Of Electrically Powered Wheelchairs
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
16-176 ANSI RESNA WC-2:2009 Section 9: Climatic Tests For Electrically Powered Wheelchairs
American National Standard For Wheelchairs - Volume 2: Additional Requirements For Wheelchairs (including Scooters) With Electrical Systems Section 9: Climatic Tests For Electrically Powered Wheelchairs
16-177 ANSI RESNA WC-2:2009 Section 10: Determination Of Obstacle-Climbing Ability Of Electrically Powered Wheelchairs
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
16-178 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
16-180 ANSI RESNA WC-2:2009 SEction 14: Power And Control Systems For Electrically Powered Wheelchairs ¿ Requirements
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
16-181 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
16-183 ANSI RESNA WC-1:2009 Section 20: Determination Of The Performance Of Stand-up Type Wheelchairs
American National Standard For Wheelchairs - Volume 1: Requirements And Test Methods For Wheelchairs (including Scooters) Section 20: Determination Of The Performance Of Stand-up Type Wheelchairs
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
16-185 ANSI RESNA WC-2:2009
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
16-187 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
16-192 ISO 7176-3 Third Edition 2012-12-15
Wheelchairs - Part 3: Determination Of Effectiveness Of Brakes
16-193 ASME A18.1-2014
Safety Standard For Platform Lifts And Stairway Chairlifts
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
16-202 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, Acceleration And Deceleration Of Electric Wheelchairs
16-205 RESNA WC-4:2017
RESNA Standard For Wheelchairs Volume 4: Wheelchairs And Transportation.

Total Product Life Cycle

Device Type ID	5137
Device	Wheelchair, Standup
Product Code	IPL
FDA Device Classification	Class 2 Medical Device
Regulation Description	Standup Wheelchair.
CFR Regulation Number	890.3900 [🔎]

Premarket Reviews
Manufacturer	Decision
SUNRISE MEDICAL (US) LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Unintended Movement	1
Break	1
Labelling, Instructions For Use Or Training Problem	1
Frame	1
Total Device Problems	4

Recalls
Manufacturer		Recall Class	Date Posted
1	The Standing Company	II	Feb-19-2014

TPLC Last Update: 2019-04-02 21:01:03