Product code IKW— Physical Medicine

BK-5371 GAD-19-BOUT PERSONAL MOBIL AID

Classification name
Utensil, Homemaking
Device class
Class 1
Regulation
21 CFR 890.5050
Advisory panel
Physical Medicine
Total cleared
12
First cleared
Most recent

Market context for product code IKW

FDA has cleared 12 devices under product code IKW between 1976 and 1983, filed by 1 applicant company. 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

Top applicants under product code IKW

Recent clearances under product code IKW

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