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Low-Frequency Multi-Function Physiotherapy Instrument

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200177

by Shenzhen Kentro Medical Electronics Co., Ltd

Identifiers

510(k) Number
K200177 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)

The Low-Frequency Multi-Function Physiotherapy Instrument is a transcutaneous nerve stimulator. It is designed to provide electrical stimulation for therapeutic purposes.

This device is identified by K-number K200177 and is regulated under product code NUH. It has received FDA 510(k) clearance as a substantially equivalent device.

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: Low-frequency Multi-function physiotherapy instrument (K200177) — FDA ..., Low-frequency Multi-function Physiotherapy… - FDA.report, K191982 FDA 510(k) - Low-Frequency Multi-function Physiother...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Kentro Medical Electronics Co., Ltd
FDA Applicant
Shenzhen Kentro Medical Electronics Co., Ltd.

Sources (1)

  • FDA 510(k) K200177 24 fields · synced Sep 26, 2026