Product code FMR— General Hospital

PATIENT TURNING AND REPOSITIONING G DEV.

Classification name
Device, Transfer, Patient, Manual
Device class
Class 1
Regulation
21 CFR 880.6785
Advisory panel
General Hospital
Total cleared
5
First cleared
Most recent

Market context for product code FMR

FDA has cleared 5 devices under product code FMR between 1977 and 1987, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code FMR

Adverse events under product code FMR

product code FMR
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code FMR

Data sourced from openFDA. This site is unofficial and independent of the FDA.