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510(k) K063465

CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE by Iomed, Inc. — Product Code EGJ

K063465 is an FDA 510(k) premarket notification submitted by Iomed, Inc. for the device "CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE". The FDA issued a decision of Substantially Equivalent on February 28, 2007. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Iomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2007
Date Received
November 16, 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

Other clearances by Iomed, Inc.

  • K060236 — MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE (March 31, 2006)
  • K033192 — RH-950 (December 22, 2003)
  • K031115 — RH-900 (July 10, 2003)
  • K001522 — TRANSQ3 (October 18, 2000)
  • K001410 — PHORESOR MODEL PM2000 (August 1, 2000)
  • K982668 — PHORESOR II,MODEL PM900 (March 2, 1999)
  • K974855 — PHORESOR II, MODEL PM900 (March 27, 1998)
  • K954126 — TRANSQ ELECTRODE PHORESOR II (January 19, 1996)
  • K934335 — PHORESOR II AUTO, MODEL PM800 MODIFICATION (July 26, 1994)
  • K932620 — RH-806/GS MODEL TRANSQ(R)2 (July 26, 1994)

Other clearances for product code EGJ

  • K242041 — STOPWET iontophoresis apparatus (SW01) (April 1, 2025)
  • K241267 — Hidroxa SE30 (October 17, 2024)
  • K232020 — Iontophoresis Electrodes (October 16, 2023)
  • 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