Comfort/Io Iontophoresis Electrodes

FDA 510(k) K060579 · Pepin Mfg., Inc.

Substantially Equivalent

510(k) numberK060579

Submission

Device name
Comfort/Io Iontophoresis Electrodes
Applicant
Pepin Mfg., Inc.
Stoughton, WI, US
Received
March 6, 2006
Decision date
April 20, 2006
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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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Questions and answers

When was Comfort/Io Iontophoresis Electrodes cleared by the FDA?

Comfort/Io Iontophoresis Electrodes (K060579) received a 510(k) decision of Substantially Equivalent on April 20, 2006, 45 days after the submission was received.

What is the product code of K060579?

The FDA product code is EGJ – Device, Iontophoresis, Other Uses, a Class II (moderate risk) device regulated under 21 CFR 890.5525.