|Recognition List Number: 026 FR Publication Date: 03/18/2011
Part B: Supplementary Information
Recognition Number 16-171: ANSI / RESNA WC-2:2009, section 4: energy consumption of electrically powered wheelchairs and scooters for determination of theoretical dis. (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) |
|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:|
Standard specifies a method for determining the energy consumption expressed as a theoretical range of electric wheelchairs and scooters intended for users whose mass does not exceed 100 kg.
If the specified maximum capacity of the device is greater than 100 kg, a custom-designed test dummy should be used to complete this test. The design of the test dummy should follow the guidelines provided in RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummies.
Manufacturers should disclose the results of the testing in the product labeling.
|Related CFR Citations and Product Codes:|
|FDA Technical Contact:|
| Laurence Coyne |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1526 |
| Silver Spring MD 20993 |
| 301/796-5650 |
| email: firstname.lastname@example.org|