Orthosis, Truncal, For Dysmenorrhea

NJB · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.3490

Classification

FDA Product Code: NJB
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 890.3490
Review panel: PM
Medical specialty: Physical Medicine
Submission type: 4
GMP exempt: Y
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 14

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown