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510(k) K030395

EMPI ACTION PATCH IONTOPHORESIS SYSTEM by Empi — Product Code EGJ

K030395 is an FDA 510(k) premarket notification submitted by Empi for the device "EMPI ACTION PATCH IONTOPHORESIS SYSTEM". The FDA issued a decision of Substantially Equivalent on April 8, 2003. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Empi has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2003
Date Received
February 5, 2003
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 Empi

  • K093324 — EMPI CONTINUUM (March 5, 2010)
  • K090922 — EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR (June 5, 2009)
  • K072946 — HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM (November 16, 2007)
  • K070427 — DUPEL TRANSPORT IONTOPHORESIS SYSTEM (May 14, 2007)
  • K061650 — SELECT TENS, MODEL 4600S (January 22, 2007)
  • K041920 — INFINITY PLUS ELECTROTHERAPY SYSTEM (January 21, 2005)
  • K042057 — INFINITY ELECTROTHERAPY SYSTEM (December 17, 2004)
  • K021100 — 300 PV COMPLETE ELECTROTHERAPY SYSTEM (June 18, 2002)
  • K991991 — DUPEL IONTOPHORESIS SYSTEM (September 10, 1999)
  • K983484 — DUPEL B.L.U.E. SMALL IONTOPHORESIS ELECTRODE (December 28, 1998)

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