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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 16-187
Standard
ANSI RESNA WC-1:2009 Section 26: Vocabulary
American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary
Scope/Abstract
This section of RESNA WC-1 specifies a vocabulary consisting of terms and definitions used in the field of manual and electrically powered wheelchairs (including scooters) and associated seating

systems. This section of RESNA WC-1 includes, but is not limited to, the preferred terms used in two or more sections of the RESNA WC-1, WC-2, WC-3, and WC-4 standards, but does not

include terms considered to be adequately defined in everyday English.

Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§890.3930 Elevator, Wheelchair, Portable Class 2 ING
§890.3900 Wheelchair, Standup Class 2 IPL
§890.3890 Wheelchair, Stair Climbing Class 2 IMK
§890.3880 Wheelchair, Special Grade Class 2 IQC
§890.3860 Wheelchair, Powered Class 2 ITI
§890.3850 Stroller, Adaptive Class 1 LBE
§890.3850 Wheelchair, Mechanical Class 1 IOR
§890.3800 Vehicle, Motorized 3-Wheeled Class 2 INI
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Angela DeMarco
  FDA/OMPT/CDRH/ODE/POS/510(K)/
  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
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