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510(k) K883462

IF-II (TM), MODEL 9800 by Medical Devices, Inc. — Product Code LIH

K883462 is an FDA 510(k) premarket notification submitted by Medical Devices, Inc. for the device "IF-II (TM), MODEL 9800". The FDA issued a decision of Substantially Equivalent on May 24, 1989. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. Medical Devices, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1989
Date Received
August 15, 1988
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 Medical Devices, Inc.

  • K002280 — PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 (February 5, 2001)
  • K930084 — MICRO-ARTHROSCOPE (September 1, 1995)
  • K940012 — SMARTBRACE ELECTRODE (December 5, 1994)
  • K943126 — ELECTROFLEX (December 5, 1994)
  • K935132 — HOME MICROCURRENT HMC (March 14, 1994)
  • K934619 — FLEXMATE (February 23, 1994)
  • K924897 — XENON ENDOSCOPIC ILLUMINATOR, MODEL XEI-300 (July 6, 1993)
  • K930053 — VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 (May 17, 1993)
  • K923914 — IF-II (TM), MODEL 7200 (November 6, 1992)
  • K920071 — MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 (July 21, 1992)

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