DeviceClearance

Product code QSB— Physical Medicine

PREGNANCY (W) EDGE

Classification name
Orthosis, Truncal, Pregnancy
Device class
Class 1
Regulation
21 CFR 890.3490
Advisory panel
Physical Medicine
Total cleared
1
First cleared
Most recent

FDA classification definition

“Provide abdominal and back support during pregnancy”

— U.S. Food and Drug Administration, device classification record for product code QSB under 21 CFR 890.3490, via openFDA

Market context for product code QSB

FDA has cleared 1 device under product code QSB, all in 1982, 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 QSB

Recent clearances under product code QSB

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