510(k) DEN110009
DEN110009 is an FDA 510(k) premarket notification submitted by Mary M. Sorg (An Individual) Dba PJ Sleeper'S for the device "RESTLESS LEG DEVICE". The FDA issued a decision of De Novo Granted on December 18, 2013. The device falls under product code OTX (Foot Wrap For Treating Restless Leg Syndrome Symptoms), a Class I device regulated under 21 CFR 890.5760.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 18, 2013
- Date Received
- January 27, 2011
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Foot Wrap For Treating Restless Leg Syndrome Symptoms
- Device Class
- Class I
- Regulation Number
- 890.5760
- Review Panel
- NE
- Submission Type
Applying compression to the muscles of the foot for the purpose of affecting nerve impulses sent to the central nervous system.