FDA product code QTC

Adult Portable Bed Rails For Medical Purposes

Physical Medicine·Class 1·21 CFR 890.5050
US regulatory classifications
US Product Code (FDA)
QTC
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 890.5050
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Medical specialty
Physical Medicine
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Adult Portable Bed Rails For Medical Purposes is a medical device type in the Physical Medicine specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.