Product code
PWC: General wellness product
FDA product code · Unclassified · General Hospital
Key facts
| Product code | PWC |
|---|---|
| Device | General wellness product |
| Device class | Unclassified |
| Review panel | General Hospital |
| Submission type | Enforcement Discretion |
| GMP exempt | Yes |
| Definition | General wellness product as detailed in the guidance for purposes of imports only: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database