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FDA 510(k)

Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)

K-Number: K191982 · 2020-09-25

ApplicantShenzhen Kentro Medical Electronics Co., Ltd.
Decision Date2020-09-25
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) is a medical device manufactured by Shenzhen Kentro Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-09-25 under approval number K191982. 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 (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)?

Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) is a medical device that received FDA 510(k) clearance on 2020-09-25. It is manufactured by Shenzhen Kentro Medical Electronics Co., Ltd.. The 510(k) number is K191982.

When was Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) approved by the FDA?

Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) received FDA 510(k) clearance on 2020-09-25, under approval number K191982.

What company makes Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)?

Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) is manufactured by Shenzhen Kentro Medical Electronics Co., Ltd..

What is the FDA product code for Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)?

The FDA product code for Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) is NUH.

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Related PubMed Literature

PMID: 40006413 Data Reconstruction Methods in Multi-Feature Fusion CNN Model for Enhanced Human Activity Recognition. Sensors (Basel, Switzerland) (2025) 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 K200177Low-frequency Multi-function physiotherapy instrument K220998Transcutaneous Electrical Nerve Stimulator, Model: KTR-405

View all 10 devices →

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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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