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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 055 Date of Entry 12/21/2020 
FR Recognition Number 16-230
Standard
RESNA ANSI  WC-2:2019 Section 25
American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 25: Batteries and Chargers for Powered Wheelchairs
Scope/Abstract
This section of RESNA WC-2specifies requirements and test methods for batteries and battery chargers intended for use with electrically powered wheelchairs. It is applicable to lead acid batteries and chargers intended for use with them. Requirements for chargers are applicable to those with a rated input voltage not greater than 250 V a.c. and a nominal output voltage not greater than 36 V.

This document is applicable to electrically powered wheelchairs, including scooters, and add-on devices, intended to carry one person with a mobility impairment.
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
Relevant FDA Guidance and/or Supportive Publications*
Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles, issued July 1995.

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 Contact
 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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