Foot Wrap For Treating Restless Leg Syndrome Symptoms
The Foot Wrap for Treating Restless Leg Syndrome Symptoms (product code OTX) is a physical medicine device that applies compression to the muscles of the foot to affect nerve impulses sent to the central nervous system, providing relief from restless leg syndrome symptoms. It is a non-invasive, wearable wrap device designed for home or clinical use. As an FDA Class 1 device under regulation 890.5760, it is subject to general controls only, which is the lowest level of FDA regulatory oversight. It falls within the Physical Medicine specialty and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- OTX
- Device Class
- FDA class 1
- Regulation Number
- 890.5760
- Medical Specialty
- Physical Medicine
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
Definition
Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN110009 | RESTLESS LEG DEVICE | Dec 18, 2013 | Unknown | Mary M. Sorg (An Individual) Dba PJ Sleeper'S |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.