Clearance Summary
RESTLESS LEG DEVICE received FDA 510(k) clearance under submission number DEN110009, sponsored by Mary M. Sorg (An Individual) Dba PJ Sleeper'S. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2013-12-18.
- Submission: DEN110009
- Applicant / Sponsor: Mary M. Sorg (An Individual) Dba PJ Sleeper'S
- Clearance pathway: Post-NSE
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5760
- Decision date: 2013-12-18
Classification & Regulation
This clearance is catalogued under FDA product code OTX and 21 CFR 890.5760, within the Physical Medicine review panel as a Class I device.