510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K880545Substantially Equivalent

Stimwear Garments, Signal I and Signal II

Stimwear, Lakewood OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880545 is the FDA 510(k) clearance record for STIMWEAR GARMENTS, SIGNAL I AND SIGNAL II, a class II device, cleared for Stimwear on under FDA product code GXY (Electrode, Cutaneous). FDA records list one 510(k) clearance for Stimwear. As of , FDA records show no recalls naming K880545.

Clearance record

Decision date
Received
(112 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Stimwear 12900 Lake Ave. Suite 1623, Lakewood OH
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