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510(k) K000574

IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE) by Wr Medical Electronics Co. — Product Code EGJ

K000574 is an FDA 510(k) premarket notification submitted by Wr Medical Electronics Co. for the device "IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)". The FDA issued a decision of Substantially Equivalent on August 9, 2000. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Wr Medical Electronics Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2000
Date Received
February 22, 2000
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 Wr Medical Electronics Co.

  • K092809 — HRV ACQUIRE (October 19, 2010)
  • K063560 — HILGER DUAL-STIM NERVE STIMULATOR (January 5, 2007)
  • K992874 — Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM (November 18, 1999)
  • K910624 — CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 (January 17, 1992)
  • K895838 — BRACKMANN EMG MONITORING SYSTEM (March 27, 1990)

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