510(k) K003260

VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460 by Metron Medical Australia, Pty, Ltd. — Product Code IPF

K003260 is an FDA 510(k) premarket notification submitted by Metron Medical Australia, Pty, Ltd. for the device "VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460". The FDA issued a decision of Substantially Equivalent on February 22, 2001. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Metron Medical Australia, Pty, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2001
Date Received
October 18, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type