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# Exempt Power Patient Transport from 510(k): Stryker
- URL: https://www.fdaweb.com/exempt-power-patient-transport-from-510-k-stryker/
- Published: 2021-05-04T12:00:00.000Z
- Updated: 2026-09-14T16:57:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149243

Stryker has petitioned FDA to exempt powered patient transport from premarket notification under section 510(k). The 4/30 [petition](https://downloads.regulations.gov/FDA-2021-P-0424-0001/attachment%5F1.pdf?ref=fdaweb.com) says: 

- the devices do not have a significant history of false or misleading claims or risks associated with their inherent characteristics;
- characteristics of the devices necessary for their safe and effective performance are well established;
- changes in the devices that could affect safety and effectiveness will either be readily detectable by users or not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and
- any changes to the devices would not be likely to result in a change in the device’s classification.