ClearanceBrief
Company ยท CN

Shenzhen Kentro Medical Electronics Co., Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2024. Name variants (Inc, Corp, punctuation) are merged.

10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter9
NGXStimulator, Muscle, Powered, For Muscle Conditioning1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Nov 5, 2024K242332Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2
Shenzhen Kentro Medical Electronics Co., Ltd., CN
NUH
Dec 8, 2023K232517Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
Shenzhen Kentro Medical Electronics Co., Ltd., CN
NUH
May 10, 2023K222870Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026,
Shenzhen Kentro Medical Electronics Co., Ltd., CN
NUH
Aug 24, 2022K220998Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
Shenzhen Kentro Medical Electronics Co., Ltd., CN
NUH
Mar 25, 2021K200177Low-frequency Multi-function physiotherapy instrument
Shenzhen Kentro Medical Electronics Co., Ltd., CN
NUH
Oct 19, 2020K200237Transcutaneous Electronic Nerve Stimulator
Shenzhen Kentro Medical Electronics Co., Ltd., CN
NUH
Sep 25, 2020K191982Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211
Shenzhen Kentro Medical Electronics Co., Ltd., CN
NUH
Jul 30, 2019K183288Transcutaneous Electrical Nerve Stimulator
Shenzhen Kentro Medical Electronics Co., Ltd., CN
NUH
Oct 17, 2018K181728Muscle Trainer
Shenzhen Kentro Medical Electronics Co., Ltd., CN
NGX
May 11, 2017K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
Shenzhen Kentro Medical Electronics Co., Ltd., CN
NUH

Latest recalls

DateFirm and productCodeLinked 510(k)
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