Product code NJB

Device name

Orthosis, Truncal, For Dysmenorrhea

Medical specialty

Physical Medicine

Device class

1

Regulation number

890.3490

Review panel

PM

Implant

N

Life sustaining/supporting

N

GMP exempt

Y

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset