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FDA 510(k)

Tens & Ems Device (TU1080)

K-Number: K242787 · 2024-12-18

ApplicantChangsha Anxiang Medical Technology Co., Ltd.
Decision Date2024-12-18
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Tens & Ems Device (TU1080) is a medical device manufactured by Changsha Anxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-18 under approval number K242787. 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 & Ems Device (TU1080)?

Tens & Ems Device (TU1080) is a medical device that received FDA 510(k) clearance on 2024-12-18. It is manufactured by Changsha Anxiang Medical Technology Co., Ltd.. The 510(k) number is K242787.

When was Tens & Ems Device (TU1080) approved by the FDA?

Tens & Ems Device (TU1080) received FDA 510(k) clearance on 2024-12-18, under approval number K242787.

What company makes Tens & Ems Device (TU1080)?

Tens & Ems Device (TU1080) is manufactured by Changsha Anxiang Medical Technology Co., Ltd..

What is the FDA product code for Tens & Ems Device (TU1080)?

The FDA product code for Tens & Ems Device (TU1080) is NGX.

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

K242567Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) K251429OTC 4-Channel Rechargeable TENS Unit K251706TENS and EMS Unit K2511873 in 1 TENS UNIT (TC1241, TC2241, TS1241) K2507593 in 1 TENS UNIT K243763Wireless TENS & EMS Unit

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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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