Cleared Traditional

K242460 - Progenix Select Stim

K242460 is an FDA 510(k) clearance for Progenix Select Stim, manufactured by Progenix, LLC. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K242460 · Progenix, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
226d
Days
Class 2
Risk

K242460 is an FDA 510(k) clearance for the Progenix Select Stim. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Progenix, LLC (Fairfax, US). The FDA issued a Cleared decision on April 2, 2025 after a review of 226 days - an extended review cycle.

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 Progenix, LLC devices

FDA 510(k) Submission Details - K242460

510(k) Number K242460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2024
Decision Date April 02, 2025
Days to Decision 226 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
78d slower than avg
Panel avg: 148d · This submission: 226d
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 157
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K242460.
TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
K250053 · Shenzhen Jiantuo Electronics Co., Ltd. · May 2025
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
POCKET TENS (EP-300)
K242815 · Hivox Biotek, Inc. · Dec 2024
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