510(k) K072372

PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE by Mego Afek — Product Code JOW

K072372 is an FDA 510(k) premarket notification submitted by Mego Afek for the device "PHLEBOPRESS MODEL 601A COMPRESSION THERAPY DEVICE". The FDA issued a decision of Substantially Equivalent on November 21, 2007. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Mego Afek has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2007
Date Received
August 23, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type