DYNATRON ION IONTOPHORESIS ELECTRODE

Device, Iontophoresis, Other Uses

DYNATRONICS CORP.

The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron Ion Iontophoresis Electrode.

Pre-market Notification Details

• Device ID: K060814
• 510k Number: K060814
• Device Name: DYNATRON ION IONTOPHORESIS ELECTRODE
• Classification: Device, Iontophoresis, Other Uses
• Applicant: DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121
• Contact: Kelvyn Cullimore, Jr
• Correspondent: Kelvyn Cullimore, Jr; DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City, UT 84121
• Product Code: EGJ
• CFR Regulation Number: 890.5525 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2006-03-27
• Decision Date: 2006-06-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20660584000090	K060814	000
20660584000083	K060814	000
20660584000076	K060814	000
20660584000069	K060814	000