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510(k) K120342

EMG RECORDING ELECTRODE ASSEMBLY by Rhythmlink International, LLC — Product Code IKT

K120342 is an FDA 510(k) premarket notification submitted by Rhythmlink International, LLC for the device "EMG RECORDING ELECTRODE ASSEMBLY". The FDA issued a decision of Substantially Equivalent on June 22, 2012. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Rhythmlink International, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2012
Date Received
February 3, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle, Diagnostic Electromyograph
Device Class
Class II
Regulation Number
890.1385
Review Panel
NE
Submission Type

Other clearances by Rhythmlink International, LLC

  • K203079 — MR Conditional Sticky Pad Electrode (February 9, 2021)
  • K200984 — Guardian Needle Electrode (May 27, 2020)
  • K191225 — EEG Electrode Template (August 5, 2019)
  • K190801 — PressOn Electrode Headset (July 10, 2019)
  • K172503 — MR Conditional Cup Electrode, MR Conditional Webb Electrode (December 1, 2017)
  • K132138 — RHYTHMLINK DISPOSABLE CONCENTRIC STIMULATING PROBE (April 11, 2014)
  • K130220 — MR CONDITIONAL PRESSON ELECTRODE (July 22, 2013)
  • K130287 — MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE (May 30, 2013)
  • K121347 — PRESSON ELECTRODE (July 12, 2012)
  • K112435 — RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT (September 22, 2011)

Other clearances for product code IKT

  • K253581 — Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable (March 15, 2026)
  • K173815 — Allergan Botox Needle Electrode (June 29, 2018)
  • K161430 — Myoject Luer Lock Needle Electrode (March 2, 2017)
  • K152984 — Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, (June 3, 2016)
  • K143433 — Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable C (August 28, 2015)
  • K112034 — TECA ELITE DISPOSABLE CONCENTRIC NEEDLES (August 12, 2011)
  • K111131 — TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES (June 17, 2011)
  • K092973 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR N (October 7, 2010)
  • K093825 — AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE (January 13, 2010)
  • K091410 — DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, (August 11, 2009)

FDA data resources