510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K082514Substantially Equivalent

Tens/ems Combo, Ems, TENS

Medihightec Medical Co., Ltd., Keelung City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082514 is the FDA 510(k) clearance record for TENS/EMS COMBO, EMS, TENS, a class II device, cleared for Medihightec Medical Co., Ltd. on under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief). FDA records list one 510(k) clearance for Medihightec Medical Co., Ltd. As of , FDA records show no recalls naming K082514.

Clearance record

Decision date
Received
(49 days to decision)
Product code
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Medihightec Medical Co., Ltd. 4f, #180, Fu 1st St.,, Keelung City, TW
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code GZJ

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