Adult Portable Bed Rails For Medical Purposes
The Adult Portable Bed Rail for Medical Purposes is a device intended to assist impaired adults, including those who are disabled, injured, or post-surgery, with transfer in and out of bed and repositioning, reducing the risk of falls or fractures during these activities. It may also help mitigate fall risk in patients with balance disorders. Classified as FDA Class 1 under regulation 890.5050, it is subject to general controls and is exempt from 510(k) premarket notification in the Physical Medicine specialty. The device excludes hospital bed guardrails and pediatric bed rails, and is not an implant or life-sustaining.
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Basic Information
- Product Code
- QTC
- Device Class
- FDA class 1
- Regulation Number
- 890.5050
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 60 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 60 registration numbers. Click on an entry to view related FDA registrations.