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FDA 510(k)

TENS and EMS Unit

K-Number: K251706 · 2025-07-30

Decision Date2025-07-30
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TENS and EMS Unit is a medical device manufactured by Changsha Anxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-30 under approval number K251706. 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 TENS and EMS Unit?

TENS and EMS Unit is a medical device that received FDA 510(k) clearance on 2025-07-30. It is manufactured by Changsha Anxiang Medical Technology Co., Ltd.. The 510(k) number is K251706.

When was TENS and EMS Unit approved by the FDA?

TENS and EMS Unit received FDA 510(k) clearance on 2025-07-30, under approval number K251706.

What company makes TENS and EMS Unit?

TENS and EMS Unit is manufactured by Changsha Anxiang Medical Technology Co., Ltd..

What is the FDA product code for TENS and EMS Unit?

The FDA product code for TENS and EMS Unit is NGX.

Other Devices by Changsha Anxiang Medical Technology Co., Ltd.

View all 8 devices →

Related Devices (Code: NGX)

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.