| ASME A18.1-2017 Safety Standard for Platform Lifts and Stairway Chairlifts |
| Recognition Number | Physical Medicine |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 16-203 |
| Extent | Complete standard |
| Standards Orgs | ASME American Society of Mechanical Engineers https://www.asme.org/ |
| STG | Physical Medicine |
| FDA Tech | John Marszalek FDA/OMPT/CDRH/OC/DICO/FEB/ 301-796-7067 john.marszalek@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 safety standard covers the design, construction, installation, operation, inspection, testing, maintenance, and repair of inclined stairway chairlifts and inclined and vertical platform lifts intended for transportation of a mobility impaired person only. The device shall have a limited vertical travel, operating speed, and platform area. Operation shall be under continuous control of the user/attendant. The device shall not penetrate more than one floor. A full passenger enclosure on the platform shall be prohibited.
| 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 |
| §890.3800 | Vehicle, Motorized 3-Wheeled | Class 2 | INI |
| There is no relevant guidance developed at this time. |