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FDA 510(k)

Tyece OTC EMS System, Model EM35

K-Number: K172241 · 2017-11-20

ApplicantTyece , Ltd.
Decision Date2017-11-20
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Tyece OTC EMS System, Model EM35 is a medical device manufactured by Tyece , Ltd.. It received FDA 510(k) clearance on 2017-11-20 under approval number K172241. 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, Model EM35?

Tyece OTC EMS System, Model EM35 is a medical device that received FDA 510(k) clearance on 2017-11-20. It is manufactured by Tyece , Ltd.. The 510(k) number is K172241.

When was Tyece OTC EMS System, Model EM35 approved by the FDA?

Tyece OTC EMS System, Model EM35 received FDA 510(k) clearance on 2017-11-20, under approval number K172241.

What company makes Tyece OTC EMS System, Model EM35?

Tyece OTC EMS System, Model EM35 is manufactured by Tyece , Ltd..

What is the FDA product code for Tyece OTC EMS System, Model EM35?

The FDA product code for Tyece OTC EMS System, Model EM35 is NGX.

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Other Devices by Tyece , Ltd.

K183454Tyece OTC EMS System

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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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