Product code IOZ— Physical Medicine

ABDUCTION PILLOW

Classification name: Splint, Abduction, Congenital Hip Dislocation
Device class: Class 1
Regulation: 21 CFR 890.3665
Advisory panel: Physical Medicine
Total cleared: 4
First cleared: 1978-03-15
Most recent: 1983-03-08

Market context for product code IOZ

FDA has cleared 4 devices under product code IOZ between 1978 and 1983, filed by 4 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

19832 clearances
19811 clearance
19781 clearance

Top applicants under product code IOZ

Warm & Form, Orthopedic Materials1 clearance
Orthomedics1 clearance
Danek Medical, Inc.1 clearance
Biomet, Inc.1 clearance

Recent clearances under product code IOZ

K830243 — ABDUCTION PILLOWWarm & Form, Orthopedic Materials·1983-03-08
K823820 — ABDUCTION PILLOWDanek Medical, Inc.·1983-01-14
K810557 — HIP ABDUCTION SPLINTOrthomedics·1981-03-13
K780375 — PAVLIK HARNESSBiomet, Inc.·1978-03-15

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