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Smart Pain Reliever, Model LT5019

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162479

by Shenzhen Dongdixin Technology Co., Ltd.

Identifiers

510(k) Number
K162479 FDA 510(k)
FDA Product Code
NUH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5890 FDA 510(k)
Regulation Number
882.5890 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Smart Pain Reliever, Model LT5019 is a home-use, over-the-counter transcutaneous electrical nerve stimulator (TENS) and powered muscle stimulator (EMS). It uses Bluetooth Low Energy to connect to a mobile app (iOS/Android) for control.

The device is supplied as a reusable system intended for home use. It has received FDA 510(k) clearance under K162479 with product code NUH and was determined to be substantially equivalent to a predicate device. No claims are made regarding sterility, single-use status, MRI safety, sizes, storage conditions, or additional authorisations beyond those stated.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: smart Elektroautos - Entdecke unsere Modelle | smart, Smart Pain Reliever, Model LT5019 (K162479) — FDA 510(k) | Innolitics, FCC ID 2AKMI-LT5019 - Smart Pain Reliever, Alle smart Modelle auf einen Blick | smart, Smart Pain Reliever, Model Lt5019 510 (k) FDA Premarket Notification ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Dongdixin Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K162479 24 fields · synced Sep 23, 2026