510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K802658Substantially Equivalent

Rodel Electroderm Pads

Rodel Products Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802658 is the FDA 510(k) clearance record for RODEL ELECTRODERM PADS, a class II device, cleared for Rodel Products Corp. on under FDA product code GYB (Media, Electroconductive). FDA records list 2 510(k) clearances for Rodel Products Corp., from to . As of , FDA records show no recalls naming K802658.

Clearance record

Decision date
Received
(67 days to decision)
Product code
GYB Media, Electroconductive
Regulation
21 CFR 882.1275
Device class
Class II
Review panel
Neurology
Applicant
Rodel Products Corp. 803 N. Front St. Suite 3, Mchenry IL
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