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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 the device name listed in this FDA 510(k) record. The listed applicant is Tyece , Ltd.. It received FDA 510(k) clearance on 2017-11-20 under 510(k) 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. The listed applicant is Tyece , Ltd.. The 510(k) number is K172241.

When did Tyece OTC EMS System, Model EM35 receive FDA 510(k) clearance?

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

Who is the listed applicant for Tyece OTC EMS System, Model EM35?

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, Model EM35?

The FDA product code for Tyece OTC EMS System, Model EM35 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 ModelK183454Tyece OTC EMS System

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

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