Product code
OTX: Foot wrap for treating restless leg syndrome symptoms
FDA product code · Class I · Neurology
Key facts
| Product code | OTX |
|---|---|
| Device | Foot wrap for treating restless leg syndrome symptoms |
| Device class | Class I |
| Regulation number | 890.5760 |
| Review panel | Neurology |
| Medical specialty | Physical Medicine |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system. |
At a glance
- None 510(k) clearances
- 1–9 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