DeviceClearance

Product code ILS— Physical Medicine

HYGIENE ADAPTORS

Classification name
Adaptor, Hygiene
Device class
Class 1
Regulation
21 CFR 890.5050
Advisory panel
Physical Medicine
Total cleared
31
First cleared
Most recent

Market context for product code ILS

FDA has cleared 31 devices under product code ILS between 1976 and 1985, filed by 10 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

Top applicants under product code ILS

Adverse events under product code ILS

product code ILS
Death
4
Injury
200
Total
204

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code ILS

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