510(k) K872040

PHORESOR II (TM), MODEL PM700 by Motion Control, Inc. — Product Code EGJ

K872040 is an FDA 510(k) premarket notification submitted by Motion Control, Inc. for the device "PHORESOR II (TM), MODEL PM700". The FDA issued a decision of Substantially Equivalent on August 4, 1987. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Motion Control, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1987
Date Received
May 27, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Other Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type