DeviceClearance

Product code PHW— Physical Medicine

BUZZY

Classification name
Cold Pack And Vibrating Massager
Device class
Class 1
Regulation
21 CFR 890.5975
Advisory panel
Physical Medicine
Total cleared
2
First cleared
Most recent

FDA classification definition

“Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture).”

— U.S. Food and Drug Administration, device classification record for product code PHW under 21 CFR 890.5975, via openFDA

Market context for product code PHW

FDA has cleared 2 devices under product code PHW between 2014 and 2023, 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 PHW

Recent clearances under product code PHW

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