QTC — Adult Portable Bed Rails For Medical Purposes Class I
FDA product code QTC covers "Adult Portable Bed Rails For Medical Purposes", a Class I medical device regulated under 21 CFR 890.5050. Submissions are reviewed by the Physical Medicine panel.
Classification Details
- Product Code
- QTC
- Device Class
- Class I
- Regulation Number
- 890.5050
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
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.