Product code
OXW: Stimulator, electrical, transcutaneous, for diabetic retinopathy
FDA product code · Not Classified · Ophthalmic
Key facts
| Product code | OXW |
|---|---|
| Device | Stimulator, electrical, transcutaneous, for diabetic retinopathy |
| Device class | Not Classified |
| Review panel | Ophthalmic |
| Submission type | Contact ODE |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through the electrodes to the patient's eyelid to create a microcurrent loop that flows through the retina. |
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
- 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