OTX · Foot Wrap For Treating Restless Leg Syndrome Symptoms
Physical Medicine · 21 CFR 890.5760 · Class 1
Overview
| Product Code | OTX |
|---|---|
| Device Name | Foot Wrap For Treating Restless Leg Syndrome Symptoms |
| Regulation | 21 CFR 890.5760 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A nonpowered lower extremity pressure wrap is a prescription device that applies mechanical pressure by wrapping around the lower extremity, such as the leg or foot, and is intended for primary Restless Leg Syndrome.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN110009 | RESTLESS LEG DEVICE | Mary M. Sorg (An Individual) Dba PJ Sleeper'S | Dec 18, 2013 | DENG |
Top Applicants
- Mary M. Sorg (An Individual) Dba PJ Sleeper'S — 1 clearance
