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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 therapeutic vibrational mattress pad, adjunct use in neonatal abstinence syndrome or neonatal opioid withdrawal syndrome
De Novo Number DEN240031
Device Name Prapela SVS hospital bassinet pad (model P01)
Requester
prapela, inc.
2 main st ste 15-219
biddeford,  ME  04005
Contact john konsin
Regulation Number880.5151
Classification Product Code
QVY  
Date Received06/17/2024
Decision Date 04/04/2025
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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