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-4039

FDA 510(k) K222870 · Shenzhen Kentro Medical Electronics Co., Ltd.

Substantially Equivalent

510(k) numberK222870

Submission

Device name
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-4039
Applicant
Shenzhen Kentro Medical Electronics Co., Ltd.
Shenzhen, CN
Received
September 22, 2022
Decision date
May 10, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

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More from Sigma Biomedical

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K242332Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342…NUH · Traditional 11/05/2024SE
K232517Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401…NUH · Traditional 12/08/2023SE
K220998Transcutaneous Electrical Nerve Stimulator, Model: KTR-405NUH · Traditional 08/24/2022SE
K200177Low-frequency Multi-function physiotherapy instrumentNUH · Traditional 03/25/2021SE
K200237Transcutaneous Electronic Nerve StimulatorNUH · Traditional 10/19/2020SE
K191982Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220…NUH · Traditional 09/25/2020SE
K183288Transcutaneous Electrical Nerve StimulatorNUH · Traditional 07/30/2019SE
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K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203NUH · Traditional 05/11/2017SE

Questions and answers

When was 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-4039 cleared by the FDA?

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-4039 (K222870) received a 510(k) decision of Substantially Equivalent on May 10, 2023, 230 days after the submission was received.

What is the product code of K222870?

The FDA product code is NUH – Stimulator, Nerve, Transcutaneous, Over-The-Counter, a Class II (moderate risk) device regulated under 21 CFR 882.5890.