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510(k) K854721

NEMECTRODYN MODEL 2 & ENDOVAC 2 by Nemectron Medical, Inc. — Product Code LIH

K854721 is an FDA 510(k) premarket notification submitted by Nemectron Medical, Inc. for the device "NEMECTRODYN MODEL 2 & ENDOVAC 2". The FDA issued a decision of Substantially Equivalent on March 6, 1986. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. Nemectron Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1986
Date Received
November 22, 1985
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 Nemectron Medical, Inc.

  • K923396 — THERMODYN (May 26, 1993)
  • K895000 — NEMECTRON MICROWAVE (July 27, 1990)
  • K862376 — NEMECTROSON MODEL 2 (July 23, 1986)
  • K854720 — NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM. (March 10, 1986)
  • K844416 — THERMOPULS E (March 12, 1985)
  • K843735 — SOFTEPIL (October 25, 1984)
  • K843734 — NEMDI (October 25, 1984)
  • K823511 — EMG BIOFEEDBACK DEVICE (March 31, 1983)
  • K820334 — NEMECTRODYN MODELS 8,7,5 (VOLS. I-IV (March 15, 1982)
  • K810513 — ELECTRODYN CII-INTERFERENTIAL MUSCLE (May 11, 1981)

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