Shenzhen Kentro Medical Electronics Co., Ltd. FDA Approvals

0 new drug approvals and 5 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)510(k)Nov 5, 2024Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Nov 5, 2024
Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)510(k)Dec 8, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Dec 8, 2023
Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039510(k)May 10, 2023Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	May 10, 2023
Transcutaneous Electrical Nerve Stimulator, Model: KTR-405510(k)Aug 24, 2022Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Aug 24, 2022
Low-frequency Multi-function physiotherapy instrument510(k)Mar 25, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Mar 25, 2021