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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 16-180: ANSI / RESNA WC-2:2009, american national standard for wheelchairs - volume 2: additional requirements for wheelchairs (including scooters) with electrical systems section 14: power and control systems for electrically powered wheelchairs ¿ requirements and test methods. (Physical Medicine)

Date of Standard: 2009. 
Addresses of Standards Development Organizations:
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
 Rehabilitation Engineering and Assistive Technology Society of North America (RESNA)
  1700 N. Moore Street
  Suite 1540
  Arlington, VA 22209-1903
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Powered Wheelchairs and Motorized 3-Wheeled Vehicles (Scooters)
Processes Affected:
510(K), IDE, PMA, PDP, Design Controls
Type of Standard:
 Test Methods, National, Vertical
Extent of Recognition:
Complete Standard and any annexes.
Related CFR Citations and Product Codes:
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 Guidance:
Additional general information on medical device EMC can be found in guidance documents on EMC in the following device areas: Respiratory and Anesthesia Devices, Ventilators, Apnea Monitors, Powered Wheelchairs and Motorized Scooters, Cardiac Pacemakers, and Implantable Defibrillators. These and any other guidance documents with additional EMC requirements should be utilized.
FDA Technical Contact:
 John Marszalek
  OMPT/CDRH/OC/DICO/FEB
  10903 New Hampshire Avenue Building 66, Room 3661
  Silver Spring MD 20993
  301/796-7067
  email: john.marszalek@fda.hhs.gov
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