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FDA 510(k)

OTC TENS & EMS Unit

K-Number: K243511 · 2025-02-10

ApplicantChangsha Anxiang Medical Technology Co., Ltd.
Decision Date2025-02-10
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OTC TENS & EMS Unit is a medical device manufactured by Changsha Anxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-02-10 under approval number K243511. 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 OTC TENS & EMS Unit?

OTC TENS & EMS Unit is a medical device that received FDA 510(k) clearance on 2025-02-10. It is manufactured by Changsha Anxiang Medical Technology Co., Ltd.. The 510(k) number is K243511.

When was OTC TENS & EMS Unit approved by the FDA?

OTC TENS & EMS Unit received FDA 510(k) clearance on 2025-02-10, under approval number K243511.

What company makes OTC TENS & EMS Unit?

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

What is the FDA product code for OTC TENS & EMS Unit?

The FDA product code for OTC TENS & EMS Unit is NGX.

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

K242787Tens & Ems Device (TU1080) 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

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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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