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FDA 510(k)

Low-frequency Multi-function physiotherapy instrument

K-Number: K200177 · 2021-03-25

ApplicantShenzhen Kentro Medical Electronics Co., Ltd.
Decision Date2021-03-25
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Low-frequency Multi-function physiotherapy instrument is a medical device manufactured by Shenzhen Kentro Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-03-25 under approval number K200177. 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 Low-frequency Multi-function physiotherapy instrument?

Low-frequency Multi-function physiotherapy instrument is a medical device that received FDA 510(k) clearance on 2021-03-25. It is manufactured by Shenzhen Kentro Medical Electronics Co., Ltd.. The 510(k) number is K200177.

When was Low-frequency Multi-function physiotherapy instrument approved by the FDA?

Low-frequency Multi-function physiotherapy instrument received FDA 510(k) clearance on 2021-03-25, under approval number K200177.

What company makes Low-frequency Multi-function physiotherapy instrument?

Low-frequency Multi-function physiotherapy instrument is manufactured by Shenzhen Kentro Medical Electronics Co., Ltd..

What is the FDA product code for Low-frequency Multi-function physiotherapy instrument?

The FDA product code for Low-frequency Multi-function physiotherapy instrument is NUH.

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Related PubMed Literature

PMID: 40006408 Improving Fall Classification Accuracy of Multi-Input Models Using Three-Axis Accelerometer and Heart Rate Variability Data. Sensors (Basel, Switzerland) (2025)

Other Devices by Shenzhen Kentro Medical Electronics Co., Ltd.

K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 K181728Muscle Trainer K183288Transcutaneous Electrical Nerve Stimulator K200237Transcutaneous Electronic Nerve Stimulator K191982Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) K220998Transcutaneous Electrical Nerve Stimulator, Model: KTR-405

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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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