Product code
RDE: Sewing machine
FDA product code · Not Classified
Key facts
| Product code | RDE |
|---|---|
| Device | Sewing machine |
| Device class | Not Classified |
| GMP exempt | Yes |
| Definition | A machine that utilizes microwave or elf radiation for fabric treatment, incorporated in a sewing machine. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None 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