| RESNA WC-4:2017 RESNA Standard for Wheelchairs Volume 4: Wheelchairs and Transportation. |
| Recognition Number | Physical Medicine |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 16-205 |
| Extent | Complete standard |
| Standards Orgs | RESNA Rehabilitation Engineering and Assistive Technology Society of North America http://www.resna.org/ |
| STG | Physical Medicine |
| FDA Tech | Kathryn Delaurentis FDA/OMPT/CDRH/ODE/DNPMD/PMDB/ 240-402-4911 kathryn.delaurentis@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Wheelchairs and Transportation of the RESNA wheelchair standards establishes requirements and test methods for WTORS, wheelchairs (including scooters), and wheelchair seating systems that are used to enhance safety for forward-facing wheelchair-seated passengers in a wide range of vehicles, including personal vans and minivans, school buses, paratransit vans, and buses. When possible and appropriate, sections of this standard may be applied to WTORS, wheechairs, and wheelchair seating systems that fall outside the defined scope. This standard specifies the design and performance requirements, and associated test methods for determining compliance with performance criteria. These test results may be used to verify manufacturers claims that a product complies with the requirements of this standard. This standard also specifies requirements for product labeling and for manufacturer literature, including pre-sale literature and instructions and warnings to installers and consumers.
| 21 CFR 890.3860 | |||
| Regulation Number | Device Name | Device Class | Product Code |
| §890.3850 | Stroller, Adaptive | Class 1 | LBE |
| §890.3850 | Wheelchair, Mechanical | Class 1 | IOR |
| §890.3860 | Wheelchair, Powered | Class 2 | ITI |
| §890.3890 | Wheelchair, Stair Climbing | Class 2 | IMK |
| §890.3900 | Wheelchair, Standup | Class 2 | IPL |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles, Issued July 1995. |