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 (last 3 years)
- 1
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).