| ISO 7176-19 Second Edition 2008-07-15 Wheelchairs Part 19: Wheeled mobility devices for use as seats in motor vehicles [Including AMENDMENT 1 (2015)] |
| Recognition Number | Physical Medicine |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 16-201 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.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.
This part of ISO 7176 applies to all manual and powered wheelchairs, including scooters, which, in addition to their primary function as wheeled mobility devices, are also likely to be used as forward-facing seats in motor vehicles by children and adults with a body mass equal to or greater than 22 kg. This part of ISO 7176 specifies wheelchair design requirements, performance requirements and associated test methods, and requirements for wheelchair labelling, presale literature, user instructions and user warnings. It applies to complete wheelchairs, including a base frame and seating system, as well as to wheelchairs equipped with add-on adaptive components designed to facilitate compliance with one or more of the requirements.
| 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 |
| §890.3880 | Wheelchair, Special Grade | Class 2 | IQC |
| §890.3890 | Wheelchair, Stair Climbing | Class 2 | IMK |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles, Issued July 1995. |