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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 16-210
Standard
RESNA ANSI  WC-2:2019 Section 4
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
Scope/Abstract
This section of RESNA WC-2 specifies a method for determining the theoretical distance range of electrically powered wheelchairs and scooters from a measurement of energy consumed over a specified distance and the nominal energy capacity of the wheelchair's battery set. It is applicable to electrically powered wheelchairs and scooters with a maximum speed not greater than 15 km/h, intended to provide indoor and/or outdoor mobility for one disabled person with a disability whose mass is within the range represented by RESNA WC-1 Sec. 11. This document also includes requirements for test reports and information disclosure.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§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
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Kathryn Delaurentis
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  240-402-4911
  kathryn.delaurentis@fda.hhs.gov
 Amir Razjouyan
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  301-796-2701
  Amir.Razjouyan@fda.hhs.gov
Standards Development Organizations
RESNA Rehabilitation Engineering and Assistive Technology Society of North America http://www.resna.org/
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Physical Medicine
*These are provided as examples and others may be applicable.
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