510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882886Substantially Equivalent

Progel (Tm) Dual Electrode Pad, Model 8535

Medical Devices Inc., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882886 is the FDA 510(k) clearance record for PROGEL (TM) DUAL ELECTRODE PAD, MODEL 8535, a class II device, cleared for Medical Devices, Inc. on under FDA product code GXY (Electrode, Cutaneous). FDA records list 49 510(k) clearances for Medical Devices, Inc., from to . As of , FDA records show no recalls naming K882886.

Clearance record

Decision date
Received
(80 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Medical Devices, Inc. 833 Third St. Southwest, St. Paul MN
Third party review
No

Clearances, product code GXY

Trailing 12 months
11 clearances under product code GXY in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code GXY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20262
May 20263
June 20262
July 20261
August 20261
September 20260
October 20260