QSB — Orthosis, Truncal, Pregnancy Class I

FDA Device Classification

FDA product code QSB covers "Orthosis, Truncal, Pregnancy", a Class I medical device regulated under 21 CFR 890.3490. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
QSB
Device Class
Class I
Regulation Number
890.3490
Submission Type
Review Panel
OB
Medical Specialty
Physical Medicine
Implant
No

Definition

Provide abdominal and back support during pregnancy

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K821836body therapeuticsPREGNANCY (W) EDGEJuly 30, 1982