510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063448Substantially Equivalent

EMG Ac/dc Suction Unit

EMG Technology Co., Ltd., Shituen Chiu, Taichung, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063448 is the FDA 510(k) clearance record for EMG AC/DC SUCTION UNIT, a class II device, cleared for Emg Technology Co., Ltd. on under FDA product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered). FDA records list 11 510(k) clearances for Emg Technology Co., Ltd., from to . As of , FDA records show no recalls naming K063448.

Clearance record

Decision date
Received
(15 days to decision)
Product code
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Emg Technology Co., Ltd. 4f-2, # 210, 38 Rd., Shituen Chiu, Taichung, TW
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code JCX

Trailing 12 months
1 clearance under product code JCX in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JCX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260