PHW — Cold Pack And Vibrating Massager Class I
FDA product code PHW covers "Cold Pack And Vibrating Massager", a Class I medical device regulated under 21 CFR 890.5975. Submissions are reviewed by the Physical Medicine panel. At least 2 recent 510(k) clearances have been granted under this product code.
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).