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510(k) K896444

IONTOPHORESIS DEVICE - ELECTRODE RH 800 by Iomed, Inc. — Product Code EGJ

K896444 is an FDA 510(k) premarket notification submitted by Iomed, Inc. for the device "IONTOPHORESIS DEVICE - ELECTRODE RH 800". The FDA issued a decision of Substantially Equivalent (with conditions) on May 10, 1990. 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
SESD (Substantially Equivalent (with conditions))
Decision Date
May 10, 1990
Date Received
November 9, 1989
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.

  • K063465 — CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE (February 28, 2007)
  • 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)
  • K932621 — RH-801/GS MODEL TRANSQ(R)1 (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