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510(k) K052019

NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE by North Coast Medical, Inc. — Product Code EGJ

K052019 is an FDA 510(k) premarket notification submitted by North Coast Medical, Inc. for the device "NORTH COAST BUFFERED IONTOPHORESIS ELECTRODE". The FDA issued a decision of Substantially Equivalent on November 4, 2005. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2005
Date Received
July 26, 2005
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

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  • K192749 — Dermadry (February 10, 2020)
  • K191436 — Saalio (October 18, 2019)
  • K170835 — Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant (June 15, 2018)
  • K170291 — IontoDC (May 1, 2017)
  • K150453 — TULA Iontophoresis System with Earset (May 20, 2015)
  • K133033 — HIDREX PSP1000 (April 8, 2015)
  • K132832 — ACTIVAPATCH ET IONTOPHORESIS PATCH (February 13, 2014)

FDA data resources