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510(k) K043047

DYNATRON IBOX IONTOPHORESIS DEVICE by Dynatronics Corp. — Product Code EGJ

K043047 is an FDA 510(k) premarket notification submitted by Dynatronics Corp. for the device "DYNATRON IBOX IONTOPHORESIS DEVICE". The FDA issued a decision of SESU on January 7, 2005. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Dynatronics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
January 7, 2005
Date Received
November 4, 2004
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 Dynatronics Corp.

  • K132057 — DYNATRON PELTIER THERMOSTIM PROBE (January 24, 2014)
  • K113250 — DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE (February 9, 2012)
  • K060814 — DYNATRON ION IONTOPHORESIS ELECTRODE (June 14, 2006)
  • K051680 — DYNATRON DX2 TRACTION UNIT (October 11, 2005)
  • K051261 — DYNATRON X3 , DYNATRON XP IR LIGHT PAD, D405 IR LIGHT PROBE (July 25, 2005)
  • K040729 — SOLARIS D890 THERAPY PROBE (June 2, 2004)
  • K031329 — DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL (October 22, 2003)
  • K010948 — DYNATRON STS RX (May 15, 2001)
  • K010565 — DYNATRON STS (May 15, 2001)
  • K993919 — DYNATRON 900 (January 3, 2000)

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