DeviceClearance

Product code NJB— Physical Medicine

MODIFICATION TO RELIEF BRIEF

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

FDA classification definition

“A truncal orthosis for dysmenorrhea is a device intended to provide pressure to acupressure points on the lower abdomen and lower back for the purpose of reducing menstrual pain symptoms including cramps, abdominal pain and backache.”

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

Market context for product code NJB

FDA has cleared 1 device under product code NJB, all in 2002, 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 NJB

Recent clearances under product code NJB

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