NJB

Orthosis, Truncal, For Dysmenorrhea

Product code

NJB

Device name

Orthosis, Truncal, For Dysmenorrhea

Device class

Class 1

21 CFR

21 CFR 890.3490

Medical specialty

Physical Medicine

Marketing pathway

510(K) Exempt

Flag

GMP exempt

510(k) clearances (last 3 years)

1

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).