LGMClass II

Chamber, Patient Isolation

General Hospital · 21 CFR 880.5450

MDR events3All time

Recalls1All time

Registered firms6Currently listed

510(k) clearances12All time

Recent MDR events

3 adverse event reports on file

Event type breakdown

Malfunction2

Other1

Most-reported manufacturers

Stackhouse, Inc.2 Cardinal Health1

Recalls

1 recall events for this product code

Life Force of Tampa, LLC
TerminatedSep 11, 2014
Life Force Chamber
The Life Force chamber is marketed and promoted as a medical device, intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. Life Force of Tampa does not have an approved application for premarket approval in effect, or an approved application for an investigat
Z-2625-2014 · View FDA record ↗

Registered firms

6 firms currently registered for this product code

510(k) clearances

12 clearances for this product code