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FDA 510(k)

Muscle Trainer

K-Number: K181728 · 2018-10-17

Decision Date2018-10-17
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Muscle Trainer 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 2018-10-17 under 510(k) 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. The listed applicant is Shenzhen Kentro Medical Electronics Co., Ltd.. The 510(k) number is K181728.

When did Muscle Trainer receive FDA 510(k) clearance?

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

Who is the listed applicant for Muscle Trainer?

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 Muscle Trainer?

The FDA product code for Muscle Trainer is NGX.

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.

View all 10 devices →

Related Devices (Code: NGX)

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.

Official Source

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