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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 the device name listed in this FDA 510(k) record. The listed applicant is Tyece , Ltd.. It received FDA 510(k) clearance on 2019-02-26 under 510(k) 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. The listed applicant is Tyece , Ltd.. The 510(k) number is K183454.

When did Tyece OTC EMS System receive FDA 510(k) clearance?

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

Who is the listed applicant for Tyece OTC EMS System?

The FDA 510(k) record lists Tyece , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Tyece , 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.

K200838Tyece OTC TENS ModelK172241Tyece OTC EMS System, Model EM35

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.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ Muscle Stimulator for Lower Back (OT01-1003)Motive Health, Inc.

Official Source

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