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510(k) K030887

LEKTROGEL, MODEL LK3001 by Inmed Ltda. — Product Code GYB

K030887 is an FDA 510(k) premarket notification submitted by Inmed Ltda. for the device "LEKTROGEL, MODEL LK3001". The FDA issued a decision of Substantially Equivalent on June 13, 2003. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Inmed Ltda. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2003
Date Received
March 21, 2003
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 Inmed Ltda.

  • K030081 — CSF400 AND CSF600 (October 6, 2003)
  • K030889 — ULTRAEKOGEL MODELS EK 2000 & EK 2001 (May 23, 2003)

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