Product code
PQY: Nonthermal shortwave therapy device indicated for over the counter use for the treatment of pain
FDA product code · Class II · Physical Medicine
Key facts
| Product code | PQY |
|---|---|
| Device | Nonthermal shortwave therapy device indicated for over the counter use for the treatment of pain |
| Device class | Class II |
| Regulation number | 890.5290 |
| Review panel | Physical Medicine |
| Medical specialty | Physical Medicine |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Nonthermal pulsed electromagnetic energy intended for over-the-counter use for the treatment of pain. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None 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