510(k) K053509

ACUBAND ACUPRESSURE WRIST BAND DEVICE by Acuband, Inc. — Product Code MVV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2006
Date Received
December 16, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Acupressure
Device Class
Class U
Regulation Number
Review Panel
NE
Submission Type