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510(k) K111717

ELECTRO-GEL by Electro-Cap Intl., Inc. — Product Code GYB

K111717 is an FDA 510(k) premarket notification submitted by Electro-Cap Intl., Inc. for the device "ELECTRO-GEL". The FDA issued a decision of Substantially Equivalent on January 5, 2012. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Electro-Cap Intl., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2012
Date Received
June 20, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type

Other clearances by Electro-Cap Intl., Inc.

  • K112319 — ELECTRO-CAP SYSTEM (January 27, 2012)
  • K780045 — ELECTRODE CAP (January 24, 1978)

Other clearances for product code GYB

  • K243749 — Jmoon Conductive Gel (April 8, 2025)
  • K220735 — Avologi Gel Primer (Model: Av25) (September 15, 2023)
  • K222770 — Conductive Gel (December 13, 2022)
  • K221724 — Conductive Gel (September 23, 2022)
  • K212325 — EEG-acp (June 15, 2022)
  • K212326 — AC Cream - Conductive paste (December 1, 2021)
  • K212787 — GT5 conductive & abrasive gel (November 8, 2021)
  • K200402 — DR-HO'S Electro Therapy Conductive Gel (November 25, 2020)
  • K191975 — Elefix V Paste for EEG & EMG (February 7, 2020)
  • K192606 — SAC2 - Electrode Cream (January 17, 2020)

FDA data resources