510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K863035Substantially Equivalent

Polyhesive R Electrodes/tens Muscle Stim Elec Ther

Medtronic, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863035 is the FDA 510(k) clearance record for POLYHESIVE R ELECTRODES/TENS MUSCLE STIM ELEC THER, a class II device, cleared for Valleylab, Inc. on under FDA product code GXY (Electrode, Cutaneous). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K863035.

Clearance record

Decision date
Received
(38 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Valleylab, Inc. 5920 Longbow Dr., Boulder CO
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