Cleared Traditional

K172451 - Dr.MUSIC 3s

K172451 is an FDA 510(k) clearance for Dr.MUSIC 3s, manufactured by Smartmedicaldevice Co., Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K172451 · Smartmedicaldevice Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
95d
Days
Class 2
Risk

K172451 is an FDA 510(k) clearance for the Dr.MUSIC 3s. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Smartmedicaldevice Co., Ltd. (Goyang-Si, KR). The FDA issued a Cleared decision on November 17, 2017 after a review of 95 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 Smartmedicaldevice Co., Ltd. devices

FDA 510(k) Submission Details - K172451

510(k) Number K172451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2017
Decision Date November 17, 2017
Days to Decision 95 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 148d · This submission: 95d
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 158
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K172451.
EV-804 OTC Pain Relief TENS
K172919 · Everyway Medical Instruments Co.,Ltd · Apr 2018
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
K171802 · Bayer Healthcare, LLC · Mar 2018
Wireless Pain Relieve Device Model: LT5018C
K173462 · Shenzhen Dongdixin Technology Co., Ltd. · Dec 2017
Avail
K172079 · Omron Healthcare, Inc. · Oct 2017
OTC Combo TENS/EMS System
K172809 · Well-Life Healthcare Limited · Oct 2017
Smart Pain Reliever, Model LT5019
K162479 · Shenzhen Dongdixin Technology Co., Ltd. · Feb 2017