RESTLESS LEG DEVICE
FDA 510(k) clearance DEN110009 · decided 2013-12-18
Clearance details
- K-number
- DEN110009
- Device name
- RESTLESS LEG DEVICE
- Applicant
- Mary M. Sorg (An Individual) Dba PJ Sleeper'S
- Decision
- Unknown
- Date received
- 2011-01-27
- Decision date
- 2013-12-18
- Days to decision
- 1056 days
- Clearance type
- Post-NSE
- Product code
- OTX
- Device class
- 1
- Regulation number
- 890.5760
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Waterford, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.