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FDA 510(k)

Digital TENS Unit

K-Number: K170145 · 2017-04-29

ApplicantShenzhen Eapply Technology Co., Ltd.
Decision Date2017-04-29
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Digital TENS Unit is a medical device manufactured by Shenzhen Eapply Technology Co., Ltd.. It received FDA 510(k) clearance on 2017-04-29 under approval number K170145. 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 Digital TENS Unit?

Digital TENS Unit is a medical device that received FDA 510(k) clearance on 2017-04-29. It is manufactured by Shenzhen Eapply Technology Co., Ltd.. The 510(k) number is K170145.

When was Digital TENS Unit approved by the FDA?

Digital TENS Unit received FDA 510(k) clearance on 2017-04-29, under approval number K170145.

What company makes Digital TENS Unit?

Digital TENS Unit is manufactured by Shenzhen Eapply Technology Co., Ltd..

What is the FDA product code for Digital TENS Unit?

The FDA product code for Digital TENS Unit is NUH.

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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.

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