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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 16-174
ANSI RESNA WC-1:2009 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
Scope/Abstract
This section of RESNA WC-1 specifies a method of measuring the seating and wheel dimensions of wheelchairs. It is applicable to wheelchairs and vehicles intended to provide indoor and outdoor mobility. at

speed up to 15 km/h for people with disabilities whose mass does not exceed 120 kg, including the following classifications from ISO 9999:1992: It does not apply to wheelchairs with a seat width of less than 212 mm (8.35 in.). This section of RESNA WC-1 does not specify nominal seating and wheel dimensions for wheelchairs.

Extent of Recognition
Complete standard
Transition Period
FDA recognition of RESNA WC-1:2009 Section 7 [Rec# 16-174] will be superseded by recognition of RESNA WC-1:2019 Section 7 [Rec# 16-213]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 16-174] until December 25, 2020. After this transition period, declarations of conformity to [Rec #16-174] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
§890.3850 Stroller, Adaptive Class 1 LBE
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3900 Wheelchair, Standup Class 2 IPL
FDA Technical Contact
 Kathryn Delaurentis
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  240-402-4911
  kathryn.delaurentis@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
RESNA Rehabilitation Engineering and Assistive Technology Society of North America http://www.resna.org/
FDA Specialty Task Group (STG)
Physical Medicine
*These are provided as examples and others may be applicable.
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