Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 16-170: ANSI / RESNA WC-2:2009, American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 3: Determination of effectiveness of brakes. (Physical Medicine)
Date of Standard: 2009. |
| Addresses of Standards 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.
Standard specifies test methods and evaluation criteria for determining the effectiveness of brakes for manual wheelchairs and electrically powered wheelchairs including scooters.
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: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §890.3800 |
Vehicle, Motorized 3-Wheeled |
Class 2 |
INI |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §890.3860 |
Wheelchair, Powered |
Class 2 |
ITI |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §890.3880 |
Wheelchair, Special Grade |
Class 2 |
IQC |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §890.3890 |
Wheelchair, Stair Climbing |
Class 3 |
IMK |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §890.3900 |
Wheelchair, Standup |
Class 2 |
IPL |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §890.3930 |
Elevator, Wheelchair, Portable |
Class 2 |
ING |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Laurence Coyne |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1526 |
| Silver Spring MD 20993 |
| 301/796-5650 |
| Email: laurence.coyne@fda.hhs.gov |
|
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