Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 16-178: ANSI / RESNA WC-1:2009, American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummies. (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: |
| Mechanical Wheelchairs, 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 the construction of test dummies with nominal masses of 25 kg, 50 kg, 75 kg, and 100 kg. The test dummies are so designed that their centers of gravity with respect to a wheelchair are located at approximately the same positions as those of an average human being of the same mass seated in a wheelchair. Any test dummies that are designed to test wheelchairs with maximum capacities greater than 100 kg should follow the principles listed in this standard. |
|
| 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 |
| §890.3850 |
Wheelchair, Mechanical |
Class 1 |
IOR |
| |
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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