510(k) K060220

PBS MODEL 701A COMPRESSION THERAPY DEVICE by Mego Afek — Product Code JOW

K060220 is an FDA 510(k) premarket notification submitted by Mego Afek for the device "PBS MODEL 701A COMPRESSION THERAPY DEVICE". The FDA issued a decision of Substantially Equivalent on February 9, 2006. 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
February 9, 2006
Date Received
January 30, 2006
Clearance Type
Special
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