510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K860210Substantially Equivalent

Elefix Electrode Cream

Nihon Kohden America Inc, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860210 is the FDA 510(k) clearance record for ELEFIX ELECTRODE CREAM, a class II device, cleared for Nihon Kohden America, Inc. on under FDA product code GYB (Media, Electroconductive). FDA records list 166 510(k) clearances for Nihon Kohden America, Inc., from to . As of , FDA records show no recalls naming K860210.

Clearance record

Decision date
Received
(160 days to decision)
Product code
GYB Media, Electroconductive
Regulation
21 CFR 882.1275
Device class
Class II
Review panel
Neurology
Applicant
Nihon Kohden America, Inc. 17112 Armstrong Ave., Irvine CA
Third party review
No

Clearances, product code GYB

Trailing 12 months

FDA records hold no clearances under product code GYB in the trailing twelve months.

FDA records show no clearances under product code GYB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GYB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260