DeviceClearance

Product code PCM— Physical Medicine

EZ-ASSIST-FILL

Classification name
Portable Liquid Oxygen Unit Stand
Device class
Class 1
Regulation
21 CFR 890.5050
Advisory panel
Physical Medicine
Total cleared
1
First cleared
Most recent

FDA classification definition

“To assist the user with refilling a portable liquid oxygen tank from a reservoir unit by holding the portable liquid oxygen tank in an upright position.”

— U.S. Food and Drug Administration, device classification record for product code PCM under 21 CFR 890.5050, via openFDA

Market context for product code PCM

FDA has cleared 1 device under product code PCM, all in 2012, filed by 1 applicant company. 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.

Top applicants under product code PCM

Recent clearances under product code PCM

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