Home / Device Classification / PHW

PHW — Cold Pack And Vibrating Massager Class I

FDA Device Classification

Classification Details

Product Code
PHW
Device Class
Class I
Regulation Number
890.5975
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K202993mmj labsBuzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro)May 15, 2023
K130631mmj labsBUZZYAugust 13, 2014