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FDA 510(k)

Tyece OTC EMS System

K-Number: K183454 · 2019-02-26

ApplicantTyece , Ltd.
Decision Date2019-02-26
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Tyece OTC EMS System is a medical device manufactured by Tyece , Ltd.. It received FDA 510(k) clearance on 2019-02-26 under approval number K183454. 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 Tyece OTC EMS System?

Tyece OTC EMS System is a medical device that received FDA 510(k) clearance on 2019-02-26. It is manufactured by Tyece , Ltd.. The 510(k) number is K183454.

When was Tyece OTC EMS System approved by the FDA?

Tyece OTC EMS System received FDA 510(k) clearance on 2019-02-26, under approval number K183454.

What company makes Tyece OTC EMS System?

Tyece OTC EMS System is manufactured by Tyece , Ltd..

What is the FDA product code for Tyece OTC EMS System?

The FDA product code for Tyece OTC EMS System is NGX.

Other Devices by Tyece , Ltd.

K172241Tyece OTC EMS System, Model EM35

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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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