510(k) K060814

DYNATRON ION IONTOPHORESIS ELECTRODE by Dynatronics Corp. — Product Code EGJ

K060814 is an FDA 510(k) premarket notification submitted by Dynatronics Corp. for the device "DYNATRON ION IONTOPHORESIS ELECTRODE". The FDA issued a decision of Substantially Equivalent on June 14, 2006. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Dynatronics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2006
Date Received
March 27, 2006
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