FDA 510(k)

OTC TENS & EMS Unit

Número K: K243511 · 2025-02-10

RequerenteChangsha Anxiang Medical Technology Co., Ltd.

Data da decisão2025-02-10

Código do produtoNGX

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

OTC TENS & EMS Unit is the device name listed in this FDA 510(k) record. The listed applicant is Changsha Anxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-02-10 under 510(k) number K243511. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Changsha Anxiang Medical Technology Co., Ltd.. The 510(k) number is K243511.

When did OTC TENS & EMS Unit receive FDA 510(k) clearance?

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

Who is the listed applicant for OTC TENS & EMS Unit?

The FDA 510(k) record lists Changsha Anxiang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Outros registros que listam Changsha Anxiang Medical Technology Co., Ltd. como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K251429OTC 4-Channel Rechargeable TENS Unit K251706TENS and EMS Unit K251187UNIDADE TENS 3 EM 1 (TC1241, TC2241, TS1241)K250759UNIDADE TENS 3 EM 1 K243763Wireless TENS & EMS Unit K242787Tens & Ems Device (TU1080)

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Fonte oficial

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