Dynatron Ion Iontophoresis Electrode
FDA 510(k) K060814 · Dynatronics Corp.
510(k) numberK060814
Submission
- Device name
- Dynatron Ion Iontophoresis Electrode
- Applicant
- Dynatronics Corp.
Salt Lake City, UT, US - Received
- March 27, 2006
- Decision date
- June 14, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EGJ – Device, Iontophoresis, Other Uses
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5525
- Specialty
- Physical Medicine
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| K192749 | DermadryEGJ · Traditional | Dermadry Laboratories, Inc. | 02/10/2020SE |
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| K150453 | TULA Iontophoresis System with EarsetEGJ · Special | Acclarent, Inc. | 05/20/2015SE |
| K133033 | Hidrex PSP1000EGJ · Traditional | Hidrex GmbH | 04/08/2015SE |
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| K043047 | Dynatron Ibox Iontophoresis DeviceEGJ · Traditional | 01/07/2005SESU |
| K040729 | Solaris D890 Therapy ProbeILY · Traditional | 06/02/2004SE |
| K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional…IMI · Traditional | 10/22/2003SE |
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Questions and answers
When was Dynatron Ion Iontophoresis Electrode cleared by the FDA?
Dynatron Ion Iontophoresis Electrode (K060814) received a 510(k) decision of Substantially Equivalent on June 14, 2006, 79 days after the submission was received.
What is the product code of K060814?
The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.