PWC — General Wellness Product Class N

FDA Device Classification

FDA product code PWC covers "General Wellness Product", a Class N medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code
PWC
Device Class
Class N
Regulation Number
Submission Type
Review Panel
HO
Medical Specialty
Unknown
Implant
No

Definition

General wellness product as detailed in the guidance for purposes of imports only: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf