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FDA 510(k)

TENS & PMS Unit

K-Number: K220005 · 2022-04-01

ApplicantShenzhen Yuehua Xinsen Technology Co., Ltd.
Decision Date2022-04-01
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TENS & PMS Unit is a medical device manufactured by Shenzhen Yuehua Xinsen Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-04-01 under approval number K220005. 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 TENS & PMS Unit?

TENS & PMS Unit is a medical device that received FDA 510(k) clearance on 2022-04-01. It is manufactured by Shenzhen Yuehua Xinsen Technology Co., Ltd.. The 510(k) number is K220005.

When was TENS & PMS Unit approved by the FDA?

TENS & PMS Unit received FDA 510(k) clearance on 2022-04-01, under approval number K220005.

What company makes TENS & PMS Unit?

TENS & PMS Unit is manufactured by Shenzhen Yuehua Xinsen Technology Co., Ltd..

What is the FDA product code for TENS & PMS Unit?

The FDA product code for TENS & PMS 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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