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FDA 510(k)

A6 OTC Pain Relief TENS

K-Number: K182753 · 2018-10-26

Decision Date2018-10-26
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

A6 OTC Pain Relief TENS 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 2018-10-26 under 510(k) number K182753. 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 A6 OTC Pain Relief TENS?

A6 OTC Pain Relief TENS is a medical device that received FDA 510(k) clearance on 2018-10-26. The listed applicant is Everyway Medical Instruments Co.,Ltd. The 510(k) number is K182753.

When did A6 OTC Pain Relief TENS receive FDA 510(k) clearance?

A6 OTC Pain Relief TENS received FDA 510(k) clearance on 2018-10-26, under 510(k) number K182753.

Who is the listed applicant for A6 OTC Pain Relief TENS?

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 A6 OTC Pain Relief TENS?

The FDA product code for A6 OTC Pain Relief TENS 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.