510(k) K072123

HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE by Biowave Corporation — Product Code GZJ

K072123 is an FDA 510(k) premarket notification submitted by Biowave Corporation for the device "HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE". The FDA issued a decision of Substantially Equivalent on February 1, 2008. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Biowave Corporation has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2008
Date Received
August 2, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type