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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K072123
Device Name HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE
Applicant
BIOWAVE CORPORATION
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
BIOWAVE CORPORATION
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/02/2007
Decision Date 02/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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