Adult Portable Bed Rails for Medical Purposes

What Is It?

An adult portable bed rail is a device intended for medical purposes to assist a patient to perform a specific function, including but not limited to assisting impaired individuals (e.g., disabled, injured, or those post-surgery or hospitalized) with transfer in and out of bed, and repositioning, to reduce risk of falling or fracture. This device may mitigate the risk of falling due to the effects of balance disorders or other medical conditions. This does not include guardrails or side rails intended for use on FDA regulated hospital beds and does not include portable bed rails used for pediatrics.

What Is FDA Product Code QTC?

Adult Portable Bed Rails For Medical Purposes is FDA product code QTC, Class 1, 21 CFR 890.5050.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2024. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.