PWCNot classified

General Wellness Product

Unknown

PWC is the FDA product code for General Wellness Product. FDA's definition for this code reads: "General wellness product as detailed in the guidance for purposes of imports only: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and 3 recalls.

Classification record

Product code: PWC
Device name: General Wellness Product
FDA definition: General wellness product as detailed in the guidance for purposes of imports only: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf
Device class: Not classified
Review panel: Unknown
Submission type: FDA code 7
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 3

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PWC

FDA records hold no clearances under product code PWC.

Recent recalls

Product code PWC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)