510(k) Premarket Notification

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Device Classification NameStimulator, Nerve, Transcutaneous, for Pain Relief
510(k) NumberK896948
Regulation Number882.5890

 

Device NameALPHA-STIM CS
ApplicantELECTROMEDICAL PRODUCTS, INC.
ContactL Kirsch
Classification Product CodeGZJ
Date Received12/13/1989
Decision Date02/23/1990
DecisionSubstantially equivalent (SE)
Classification Advisory Committee
Neurology
Review Advisory CommitteeNeurology
Statement/Summary/Purged StatusPurged, no summary or statement
TypeTraditional
Reviewed by Third PartyNo