510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QTCClass I

Adult Portable Bed Rails For Medical Purposes

21 CFR 890.5050 / Physical Medicine
FDA source (opens on fda.gov)

QTC is the FDA product code for Adult Portable Bed Rails For Medical Purposes, a class I device type, regulated under 21 CFR 890.5050. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and 2 recalls.

Classification record

Product code
QTC
Device name
Adult Portable Bed Rails For Medical Purposes
FDA 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.
Regulation
21 CFR 890.5050
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 58 companies shown, in name order