510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K222453Substantially Equivalent

Self-adhesive Electrode

Guangdong Comytens Medical Technology Co., Ltd., Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222453 is the FDA 510(k) clearance record for Self-adhesive Electrode, a class II device, cleared for Guangdong Comytens Medical Technology Co., Ltd. on under FDA product code GXY (Electrode, Cutaneous). FDA records list one 510(k) clearance for Guangdong Comytens Medical Technology Co., Ltd. As of , FDA records show no recalls naming K222453.

Clearance record

Decision date
Received
(81 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Guangdong Comytens Medical Technology Co., Ltd. Bldg. A-102, # 24, Jiangjunmao Industriual Zone, Shenzhen, CN
510(k) summary
Summary PDF
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