| ISO 7176-2 Third edition 2017-10 Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs |
| Recognition Number | Physical Medicine |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 16-202 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Physical Medicine |
| FDA Tech | Angela DeMarco FDA/OMPT/CDRH/ODE/POS/510(K)/ 301-796-4471 angela.demarco@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 document specifies test methods for determining the dynamic stability of electrically powered wheelchairs.This document is applicable to electrically powered wheelchairs, including scooters, with a maximum nominal speed not exceeding 15 km/h, intended to carry one person. This document is not applicable to manual wheelchairs with add-on power kits used for, or to assist, propulsion.
| Regulation Number | Device Name | Device Class | Product Code |
| §890.3930 | Elevator, Wheelchair, Portable | Class 2 | ING |
| §890.3900 | Wheelchair, Standup | Class 2 | IPL |
| §890.3890 | Wheelchair, Stair Climbing | Class 2 | IMK |
| §890.3880 | Wheelchair, Special Grade | Class 2 | IQC |
| §890.3860 | Wheelchair, Powered | Class 2 | ITI |
| §890.3850 | Wheelchair, Mechanical | Class 1 | IOR |
| §890.3800 | Vehicle, Motorized 3-Wheeled | Class 2 | INI |
| Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles, Issued July 1995. |