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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name foot wrap for treating restless leg syndrome symptoms
De Novo Number DEN110009
510(K) Number K102707
Device Name RESTLESS LEG DEVICE
Requester
mary m. sorg (an individual) dba pj sleeper's
2210 elk creek road
waterford,  PA  16441
Contact mary m sorg
Regulation Number890.5760
Classification Product Code
OTX  
Date Received01/27/2011
Decision Date 12/18/2013
Decision granted (DENG)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
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