FDA Exempts Powered Wheel Stretchers From 510(k) Requirements

January 14, 2020

The FDA has agreed with Stryker’s petition for excusing battery-powered wheeled stretchers from premarket notification requirements and the agency will issue an order exempting the devices under certain conditions.

The agency will require analysis and clinical testing to show that the safety controls prevent user falls, that the devices can withstand the user’s weight and can handle “external force,” among other requirements.

The device, defined as “a battery-powered table with wheels” intended for use by patients who cannot move independently and must stay in a prone or supine position, will continue to be categorized as Class II.

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