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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 053 Date of Entry 12/23/2019 
FR Recognition Number 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
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
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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FDA recognition of RESNA WC-1:2009 Section 7 [Rec# 16-174] will be superseded by recognition of RESNA WC-1:2019 Section 7 [Rec# 16-213].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
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.