Cleared Traditional

K242815 - POCKET TENS (EP-300)

K242815 is an FDA 510(k) clearance for POCKET TENS (EP-300), 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 90-day FDA review.

K242815 · Hivox Biotek, Inc. · Neurology device
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Dec 2024
Decision
90d
Days
Class 2
Risk

K242815 is an FDA 510(k) clearance for the POCKET TENS (EP-300). 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 December 17, 2024 after a review of 90 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 - K242815

510(k) Number K242815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2024
Decision Date December 17, 2024
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 148d · This submission: 90d
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 149
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K242815.
Patch-TEA (Model TRI-21)
K243613 · Transtimulation Research, Inc. · Apr 2025
Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)
K250033 · Guangzhou Pinzhi Medical Technology Co., Ltd. · Apr 2025
Progenix Select Stim
K242460 · Progenix, LLC · Apr 2025
Nooro Body & Foot Stimulator (SM9141, SM9142)
K243334 · Xf Agencija Limited · Nov 2024
Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
K242332 · Shenzhen Kentro Medical Electronics Co., Ltd. · Nov 2024
Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
K242567 · Changsha Anxiang Medical Technology Co., Ltd. · Nov 2024