Cleared Special

K173462 - Wireless Pain Relieve Device Model: LT5018C

K173462 is an FDA 510(k) clearance for Wireless Pain Relieve Device Model: LT5018C, manufactured by Shenzhen Dongdixin Technology Co., Ltd.. The device is a Class 2 Neurology device with product code NUH cleared through the Special 510(k) pathway after a 30-day FDA review.

K173462 · Shenzhen Dongdixin Technology Co., Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
30d
Days
Class 2
Risk

K173462 is an FDA 510(k) clearance for the Wireless Pain Relieve Device Model: LT5018C. 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 December 8, 2017 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K173462

510(k) Number K173462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2017
Decision Date December 08, 2017
Days to Decision 30 days
Submission Type Special
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
119d faster than avg
Panel avg: 149d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 230
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K173462.
Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
K181207 · Everyway Medical Instruments Co., Ldt. · Jun 2018
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
HIVOX OTC Electrical Stimulator
K171803 · Hivox Biotek, Inc. · Nov 2017
Dr.MUSIC 3s
K172451 · Smartmedicaldevice Co., Ltd. · Nov 2017
Mytens Model: BW-TSX
K171026 · Bewell Connect Corp. · Nov 2017
K173462 · Wireless Pain Relieve Device Model: LT5018C
Download PDF FDA Summary Shenzhen Dongdixin Te…