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FDA 510(k)

Everyway Analog OTC TENS, model N103A/N302

K-Number: K202849 · 2020-12-22

Decision Date2020-12-22
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Everyway Analog OTC TENS, model N103A/N302 is the device name listed in this FDA 510(k) record. The listed applicant is Everyway Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2020-12-22 under 510(k) number K202849. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Everyway Analog OTC TENS, model N103A/N302?

Everyway Analog OTC TENS, model N103A/N302 is a medical device that received FDA 510(k) clearance on 2020-12-22. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K202849.

When did Everyway Analog OTC TENS, model N103A/N302 receive FDA 510(k) clearance?

Everyway Analog OTC TENS, model N103A/N302 received FDA 510(k) clearance on 2020-12-22, under 510(k) number K202849.

Who is the listed applicant for Everyway Analog OTC TENS, model N103A/N302?

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

What is the FDA product code for Everyway Analog OTC TENS, model N103A/N302?

The FDA product code for Everyway Analog OTC TENS, model N103A/N302 is NUH.

Other records listing Everyway Medical Instruments 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.

View all 13 devices →

Related Devices (Code: NUH)

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.

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.