510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012463Substantially Equivalent

Lifecare 5*5 Cm Square, Lifecare 4*4 Cm Square, Lifecare 5 Cm Round, Lifecare 7.5 Cm Round, Lifecare 4*6 Cm Oval

Everyway Medical Instruments Co., Ltd., Shen Keng Hsiang,Taipei Hsien, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012463 is the FDA 510(k) clearance record for LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL, a class II device, cleared for Everyway Medical Instruments Co.,Ltd on under FDA product code GXY (Electrode, Cutaneous). FDA records list 29 510(k) clearances for Everyway Medical Instruments Co.,Ltd, from to . As of , FDA records show no recalls naming K012463.

Clearance record

Decision date
Received
(188 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Everyway Medical Instruments Co.,Ltd 3 Floor #5 Ln.155 Bei-Shend Rd., Shen Keng Hsiang,Taipei Hsien, TW
510(k) summary
Statement
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