• 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 16-209
ANSI RESNA WC-1:2019 Section 3 American National Standard for Wheelchairs - Volume 1: Additional Requirements for Wheelchairs (including Scooters) Section 3: Determination of effectiveness of brakes
Scope/Abstract
This section of RESNA WC-1 specifies test methods for the measurement of the effectiveness of brakes of manual wheelchairs and powered wheelchairs, including scooters, intended to carry one person, with a maximum speed not exceeding 15 km/h. It also specifies disclosure requirements for the manufacturer.
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FDA recognition of RESNA WC-1:2009 Section 3 [Rec# 16-170] will be superseded by recognition of RESNA WC-1:2019 Section 3 [Rec# 16-209]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 16-170] until December 25, 2020. After this transition period, declarations of conformity to [Rec # 16-170] 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
§890.3860 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
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3850 Stroller, Adaptive Class 1 LBE
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.
-
-