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FDA 510(k)

Everyway OTC EMS, Model EV-805

K-Number: K162744 · 2017-08-03

ApplicantEveryway Medical Instrument Co., Ltd.
Decision Date2017-08-03
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Everyway OTC EMS, Model EV-805 is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2017-08-03 under 510(k) number K162744. 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 Everyway OTC EMS, Model EV-805?

Everyway OTC EMS, Model EV-805 is a medical device that received FDA 510(k) clearance on 2017-08-03. The listed applicant is Everyway Medical Instrument Co., Ltd.. The 510(k) number is K162744.

When did Everyway OTC EMS, Model EV-805 receive FDA 510(k) clearance?

Everyway OTC EMS, Model EV-805 received FDA 510(k) clearance on 2017-08-03, under 510(k) number K162744.

Who is the listed applicant for Everyway OTC EMS, Model EV-805?

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

What is the FDA product code for Everyway OTC EMS, Model EV-805?

The FDA product code for Everyway OTC EMS, Model EV-805 is NGX.

Other records listing Everyway Medical Instrument 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.

K161349Everyway Incontinence Stimulation 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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