Cleared Traditional

K162479 - Smart Pain Reliever, Model LT5019

K162479 is an FDA 510(k) clearance for Smart Pain Reliever, manufactured by Shenzhen Dongdixin Technology Co., Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K162479 · Shenzhen Dongdixin Technology Co., Ltd. · Neurology device
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Feb 2017
Decision
155d
Days
Class 2
Risk

K162479 is an FDA 510(k) clearance for the Smart Pain Reliever, Model LT5019. Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 8, 2017 after a review of 155 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 Shenzhen Dongdixin Technology Co., Ltd. devices

FDA 510(k) Submission Details - K162479

510(k) Number K162479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2016
Decision Date February 08, 2017
Days to Decision 155 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
7d slower than avg
Panel avg: 148d · This submission: 155d
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 219
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K162479.
Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
K170205 · Shenzhen Kentro Medical Electronics Co., Ltd. · May 2017
Digital TENS Unit
K170145 · Shenzhen Eapply Technology Co., Ltd. · Apr 2017
Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13
K162517 · Jkh Health Co., Ltd. · Apr 2017
CP Relief Wand-OTC
K162630 · Mid-America Medical Innovations, LLC · Dec 2016
WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A
K161453 · Well-Life Healthcare Limited · Dec 2016
Electronic Pulse Stimulator
K160508 · Beijing Choice Electronic Technololgy Co., Ltd. · Nov 2016