Everyway OTC EMS, Model EV-805
K-Number: K162744 · 2017-08-03
Decision Date2017-08-03
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Everyway OTC EMS, Model EV-805 is a medical device manufactured by Everyway Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2017-08-03 under approval 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. It is manufactured by Everyway Medical Instrument Co., Ltd.. The 510(k) number is K162744.
When was Everyway OTC EMS, Model EV-805 approved by the FDA?
Everyway OTC EMS, Model EV-805 received FDA 510(k) clearance on 2017-08-03, under approval number K162744.
What company makes Everyway OTC EMS, Model EV-805?
Everyway OTC EMS, Model EV-805 is manufactured by Everyway Medical Instrument Co., Ltd..
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.
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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.