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510(k) K092780

INF 4160 PLUS, MODEL D-FJ31F by Fuji Dynamics Limited — Product Code LIH

K092780 is an FDA 510(k) premarket notification submitted by Fuji Dynamics Limited for the device "INF 4160 PLUS, MODEL D-FJ31F". The FDA issued a decision of Substantially Equivalent on January 7, 2010. 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
January 7, 2010
Date Received
September 10, 2009
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

  • K063642 — FD EMS, MODEL # D-FJ30E (December 13, 2007)
  • K052813 — FD TENS 2030, MODEL DFJ24T (January 25, 2006)
  • K043407 — INF 4160, MODEL D-FJ27F (February 11, 2005)
  • 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)
  • 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)
  • K070890 — EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 (June 29, 2007)

FDA data resources