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510(k) K190801

PressOn Electrode Headset by Rhythmlink International, LLC — Product Code GXZ

K190801 is an FDA 510(k) premarket notification submitted by Rhythmlink International, LLC for the device "PressOn Electrode Headset". The FDA issued a decision of Substantially Equivalent on July 10, 2019. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Rhythmlink International, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2019
Date Received
March 29, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle
Device Class
Class II
Regulation Number
882.1350
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)
  • 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)
  • K120342 — EMG RECORDING ELECTRODE ASSEMBLY (June 22, 2012)
  • K112435 — RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT (September 22, 2011)

Other clearances for product code GXZ

  • K241045 — Disposable Subdermal Needle Electrode, Corkscrew (December 11, 2024)
  • K232581 — Medical Disposable Sterile Needle Electrode (December 4, 2023)
  • K231691 — Phantom XL Insulated Dilators (June 29, 2023)
  • K200984 — Guardian Needle Electrode (May 27, 2020)
  • K192603 — Spes Medica Subdermal Needle Electrodes (November 22, 2019)
  • K161566 — DMS Disposable Subdermal Needle Electrodes (December 21, 2016)
  • K142470 — E-Shield Multi-paried Subdermal Needle Electrodes (November 5, 2014)
  • K140200 — E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES (July 18, 2014)
  • K130220 — MR CONDITIONAL PRESSON ELECTRODE (July 22, 2013)
  • K130136 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUB (July 19, 2013)

FDA data resources