Product code KTD— Physical Medicine

ABDOMINAL BINDER

Classification name: Orthosis, Abdominal
Device class: Class 1
Regulation: 21 CFR 890.3490
Advisory panel: Physical Medicine
Total cleared: 3
First cleared: 1978-03-02
Most recent: 1982-12-30

Market context for product code KTD

FDA has cleared 3 devices under product code KTD between 1978 and 1982, filed by 2 applicant companies. 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.

Clearances per year

19822 clearances
19781 clearance

Top applicants under product code KTD

Warm & Form, Orthopedic Materials2 clearances
Biomet, Inc.1 clearance

Recent clearances under product code KTD

K823663 — ABDOMINAL BINDERWarm & Form, Orthopedic Materials·1982-12-30
K823164 — ABDOMINAL BINDERWarm & Form, Orthopedic Materials·1982-11-16
K780229 — ABDOMINAL BELTBiomet, Inc.·1978-03-02

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