Cleared Traditional

K260425 - TENS / EMS DEVICE (FT-247 Series) (FT-247

K260425 is an FDA 510(k) clearance for TENS / EMS DEVICE (FT-247 Series) (FT-247, manufactured by Hivox Biotek, Inc.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K260425 · Hivox Biotek, Inc. · Neurology device
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Jun 2026
Decision
126d
Days
Class 2
Risk

K260425 is an FDA 510(k) clearance for the TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Hivox Biotek, Inc. (New Taipei City, TW). The FDA issued a Cleared decision on June 16, 2026 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hivox Biotek, Inc. devices

FDA 510(k) Submission Details - K260425

510(k) Number K260425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2026
Decision Date June 16, 2026
Days to Decision 126 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 148d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUH Device Classification - Class 2, Special Controls

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 150
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K260425.
TENS 7000 Rechargeable 4 Channel (TENS 7000H)
K260412 · Shenzhen Dongdixin Technology Co., Ltd. · Jun 2026
TENS/EMS device (GUSE01)
K253896 · Globalcare Medical Technology Co., Ltd. · Mar 2026
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
K253305 · Shenzhen Jiantuo Electronics Co., Ltd. · Dec 2025
VEINOPLUS Back
K251958 · Dynapulse Medical · Dec 2025
TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
K253740 · Hong Qiangxing (Shenzhen) Electronics Limited · Dec 2025
Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
K252688 · Bozhou Rongjian Medical Appliance Co., Ltd. · Nov 2025