FDA product code OTX: Foot Wrap For Treating Restless Leg Syndrome Symptoms
OTX is the FDA product code for foot wrap for treating restless leg syndrome symptoms. It is a Class I device, regulated under 21 CFR 890.5760 and reviewed by the Neurology panel. Devices under OTX reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system.
Classification
| Field | Value |
|---|---|
| Device name | Foot Wrap For Treating Restless Leg Syndrome Symptoms |
| Device class | Class I |
| Regulation | 21 CFR 890.5760 |
| Review panel | NE — Neurology |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Recalls for OTX devices
openFDA lists no recalls for product code OTX.
Frequently asked questions
What is FDA product code OTX?
OTX is the FDA product code for foot wrap for treating restless leg syndrome symptoms. It is a Class I device, regulated under 21 CFR 890.5760 and reviewed by the Neurology panel.
What device class is OTX?
Class I, regulation 21 CFR 890.5760. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OTX
- Run a recall and safety report across every OTX manufacturer
- Watch product code OTX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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