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FDA 510(k)

Muscle Trainer

K-Number: K181728 · 2018-10-17

ApplicantShenzhen Kentro Medical Electronics Co., Ltd.
Decision Date2018-10-17
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Muscle Trainer is a medical device manufactured by Shenzhen Kentro Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2018-10-17 under approval number K181728. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Muscle Trainer?

Muscle Trainer is a medical device that received FDA 510(k) clearance on 2018-10-17. It is manufactured by Shenzhen Kentro Medical Electronics Co., Ltd.. The 510(k) number is K181728.

When was Muscle Trainer approved by the FDA?

Muscle Trainer received FDA 510(k) clearance on 2018-10-17, under approval number K181728.

What company makes Muscle Trainer?

Muscle Trainer is manufactured by Shenzhen Kentro Medical Electronics Co., Ltd..

What is the FDA product code for Muscle Trainer?

The FDA product code for Muscle Trainer is NGX.

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

K170205Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 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) K200177Low-frequency Multi-function physiotherapy instrument 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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