Product code ISR— Physical Medicine

GAIR TRAINING BELT

Classification name
Band Or Belt, Pelvic Support
Device class
Class 1
Regulation
21 CFR 890.3025
Advisory panel
Physical Medicine
Total cleared
1
First cleared
Most recent

Market context for product code ISR

FDA has cleared 1 device under product code ISR, all in 1979, 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.

Top applicants under product code ISR

Recent clearances under product code ISR

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