510(k) DEN110009
- Device
- RESTLESS LEG DEVICE
- Applicant
- Mary M. Sorg (An Individual) Dba PJ Sleeper'S
- 510(k) number
- DEN110009
- Product code
- OTX
- Decision
- Unknown (DENG)
- Decision date
- 2013-12-18
- Date received
- 2011-01-27
- Regulation
- 890.5760
- Classification name
- Foot Wrap For Treating Restless Leg Syndrome Symptoms
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- MARY M SORG
- Address
- 2210 Elk Creek Rd. Waterford PA US 16441 16441
FDA Registration Numbers#
- 3023229437
- 3012951155
- 3016970619
- 1063312
- 3011919098
- 1450371
- 3042251637
- 3014150341
- 3017910381
- 3006621348
- 3013152643
Source Documents#
510(k) summary PDF not indicated by FDA