Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Wireless TENS & EMS Unit

K-Number: K243763 · 2025-03-12

ApplicantChangsha Anxiang Medical Technology Co., Ltd.
Decision Date2025-03-12
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Wireless TENS & EMS Unit is a medical device manufactured by Changsha Anxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-03-12 under approval number K243763. 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 Wireless TENS & EMS Unit?

Wireless TENS & EMS Unit is a medical device that received FDA 510(k) clearance on 2025-03-12. It is manufactured by Changsha Anxiang Medical Technology Co., Ltd.. The 510(k) number is K243763.

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

Wireless TENS & EMS Unit received FDA 510(k) clearance on 2025-03-12, under approval number K243763.

What company makes Wireless TENS & EMS Unit?

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

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

The FDA product code for Wireless 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

View all 8 devices →

Related Devices (Code: NGX)

K152420AK Body Toning DeviceAk Beauty Enterprises, LLC K161974SLENDERTONE® Connect Abs, Type 570Bio-Medical Research, Ltd. K152480Revitive Medic; Revitive MV; Revitive LVActegy , Ltd. K151722Slim UP ULTRAAime Medical, Inc. K172876PowerDot PD-01MSmartmissimo Technologies Pte, Ltd. K172241Tyece OTC EMS System, Model EM35Tyece , Ltd.

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.

↑