• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 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
Scope/Abstract
This section of RESNA WC-1 specifies methods for the determination of wheelchair dimensions and mass. This includes specific methods for the determination of outside dimensions when the wheelchair is occupied by a reference occupant and the required maneuvering space needed for wheelchair maneuvers commonly carried out in daily life. This section specifies requirements for the disclosure of the dimensions and masses and contains five informative Annexes. Annex A specifies methods for the determination of technical dimensions that can be important to the performance of the wheelchair. Annex B provides detailed information about pivot width and reversing width. Annex C provides detailed information about the turning diameter. Annex D provides details on determining the wheelchair longitudinal axis and wheelchair centerpoint. Annex E provides technical guidelines and interpretation for many of the measurements specified to facilitate improved understanding, design and construction of wheelchairs. This section of RESNA WC-1 is applicable to manual wheelchairs and electrically powered wheelchairs (including scooters).
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FDA recognition of RESNA WC-1:2009 Section 5 [Rec# 16-172] will be superseded by recognition of RESNA WC-1:2019 Section 5 [Rec# 16-211]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 16-172] until December 25, 2020. After this transition period, declarations of conformity to [Rec # 16-1172] 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
 Angela DeMarco
  FDA/OC/CDRH/OPEQ/ORP/DRPI/
  301-796-4471
  angela.demarco@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.
-
-