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510(k) K961261

DYNATRON 525 by Dynatronics Corp. — Product Code LIH

K961261 is an FDA 510(k) premarket notification submitted by Dynatronics Corp. for the device "DYNATRON 525". The FDA issued a decision of Substantially Equivalent on September 5, 1996. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. Dynatronics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1996
Date Received
April 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interferential Current Therapy
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
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)
  • K043047 — DYNATRON IBOX IONTOPHORESIS DEVICE (January 7, 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)

Other clearances for product code LIH

  • K231575 — Vecttor VT-300 (February 8, 2024)
  • K202725 — ETD4000 (March 26, 2021)
  • K183692 — Avid IF2 (June 12, 2019)
  • K122944 — GEMORE TRUE SINE INTERFERENTIAL STIMULATOR (December 21, 2012)
  • K121662 — VECTTOR VT-200 (November 21, 2012)
  • K110509 — EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 (June 20, 2011)
  • K100246 — MAX-IF1000 (November 24, 2010)
  • K092780 — INF 4160 PLUS, MODEL D-FJ31F (January 7, 2010)
  • K092763 — IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D (October 8, 2009)
  • K090023 — IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E (January 30, 2009)

FDA data resources