510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260425Substantially Equivalent

TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)

Hivox Biotek Inc., New Taipei City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K260425 is the FDA 510(k) clearance record for TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237), a class II device, cleared for Hivox Biotek, Inc. on under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter). FDA's definition for product code NUH reads: "TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES". FDA records list 18 510(k) clearances for Hivox Biotek, Inc., from to . As of , FDA records show no recalls naming K260425.

Clearance record

Decision date
Received
(126 days to decision)
Product code
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Hivox Biotek, Inc. 5f., # 123, Xingde Rd., Sanchong District, New Taipei City, TW
510(k) summary
Statement
Third party review
No

Clearances, product code NUH

Trailing 12 months
10 clearances under product code NUH in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code NUH, trailing twelve months
MonthClearances
November 20253
December 20253
January 20260
February 20260
March 20261
April 20260
May 20260
June 20262
July 20260
August 20260
September 20261
October 20260