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FDA 510(k)

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405

K-Number: K220998 · 2022-08-24

ApplicantShenzhen Kentro Medical Electronics Co., Ltd.
Decision Date2022-08-24
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kentro Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2022-08-24 under 510(k) number K220998. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Transcutaneous Electrical Nerve Stimulator, Model: KTR-405?

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 is a medical device that received FDA 510(k) clearance on 2022-08-24. The listed applicant is Shenzhen Kentro Medical Electronics Co., Ltd.. The 510(k) number is K220998.

When did Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 receive FDA 510(k) clearance?

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 received FDA 510(k) clearance on 2022-08-24, under 510(k) number K220998.

Who is the listed applicant for Transcutaneous Electrical Nerve Stimulator, Model: KTR-405?

The FDA 510(k) record lists Shenzhen Kentro Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transcutaneous Electrical Nerve Stimulator, Model: KTR-405?

The FDA product code for Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 is NUH.

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Other records listing Shenzhen Kentro Medical Electronics Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242332Transcutaneous 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)K232517Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)K222870Transcutaneous 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-4039K200177Low-frequency Multi-function physiotherapy instrumentK200237Transcutaneous Electronic Nerve StimulatorK191982Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)

View all 10 devices →

Related Devices (Code: NUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K253740TENS&EMS (HZ9151B, HZ9151C, HZ9151D)Hong Qiangxing (Shenzhen) Electronics LimitedK251958VEINOPLUS BackDynapulse Medical

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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