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FDA 510(k)

Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203

K-Number: K170205 · 2017-05-11

ApplicantShenzhen Kentro Medical Electronics Co., Ltd.
Decision Date2017-05-11
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 is a medical device manufactured by Shenzhen Kentro Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2017-05-11 under approval number K170205. 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 Therapy Instrument /Model: KTR-201, KTR-202, KTR-203?

Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 is a medical device that received FDA 510(k) clearance on 2017-05-11. It is manufactured by Shenzhen Kentro Medical Electronics Co., Ltd.. The 510(k) number is K170205.

When was Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 approved by the FDA?

Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 received FDA 510(k) clearance on 2017-05-11, under approval number K170205.

What company makes Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203?

Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 is manufactured by Shenzhen Kentro Medical Electronics Co., Ltd..

What is the FDA product code for Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203?

The FDA product code for Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 is NUH.

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

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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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