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510(k) K043407

INF 4160, MODEL D-FJ27F by Fuji Dynamics Limited — Product Code LIH

K043407 is an FDA 510(k) premarket notification submitted by Fuji Dynamics Limited for the device "INF 4160, MODEL D-FJ27F". The FDA issued a decision of Substantially Equivalent on February 11, 2005. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. Fuji Dynamics Limited has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2005
Date Received
December 10, 2004
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 Fuji Dynamics Limited

  • K092780 — INF 4160 PLUS, MODEL D-FJ31F (January 7, 2010)
  • K063642 — FD EMS, MODEL # D-FJ30E (December 13, 2007)
  • K052813 — FD TENS 2030, MODEL DFJ24T (January 25, 2006)
  • K041164 — L-TENS (May 20, 2004)
  • K994266 — FDTENS 2010 (July 6, 2000)
  • K994265 — MEDISANA DIGITAL TENS (July 6, 2000)

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