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# FDA Denies Stryker Patient Transport Exemption
- URL: https://www.fdaweb.com/fda-denies-stryker-patient-transport-exemption/
- Published: 2021-10-20T12:00:00.000Z
- Updated: 2026-09-14T17:19:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150405

FDA has denied a 4/30 Stryker Medical petition seeking a Class 2 510(k) exemption for powered patient transport, all other powered patient transport. The FDA denial [letter](https://downloads.regulations.gov/FDA-2021-P-0424-0006/attachment%5F1.pdf?ref=fdaweb.com) says the devices are motorized units used to mitigate mobility impairment caused by injury or disease by moving a person from one location or level to another, such as up and down flights of stairs, but does not include motorized three-wheeled vehicles or wheelchairs.

FDA says it has determined that premarket notification is necessary to assure the safety and effectiveness of the devices. “Your petition failed to provide information that would support granting an exemption from premarket notification for all such devices within this ‘all other powered patient transport’ device type,” the letter says. “Due to the absence of this information, we are denying your petition.”