OTX
- Product code
- OTX
- Device name
- Foot Wrap For Treating Restless Leg Syndrome Symptoms
- Device class
- Class 1
- 21 CFR
- 21 CFR 890.5760
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification definition
Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system.
Official FDA classification page: OTX
Classification and pathway per current FDA publications. Data from openFDA (CC0).