QTC

Adult Portable Bed Rails For Medical Purposes

Product code

QTC

Device name

Adult Portable Bed Rails For Medical Purposes

Device class

Class 1

21 CFR

21 CFR 890.5050

Medical specialty

Physical Medicine

Marketing pathway

510(K) Exempt

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).