FDA 510(k)

Wireless TENS/EMS, Bruno, Aela

Número K: K220997 · 2022-09-01

Data da decisão2022-09-01

Código do produtoNUH

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wireless TENS/EMS, Bruno, Aela is the device name listed in this FDA 510(k) record. The listed applicant is Zmi Elecronics , Ltd.. It received FDA 510(k) clearance on 2022-09-01 under 510(k) number K220997. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Wireless TENS/EMS, Bruno, Aela?

Wireless TENS/EMS, Bruno, Aela is a medical device that received FDA 510(k) clearance on 2022-09-01. The listed applicant is Zmi Elecronics , Ltd.. The 510(k) number is K220997.

When did Wireless TENS/EMS, Bruno, Aela receive FDA 510(k) clearance?

Wireless TENS/EMS, Bruno, Aela received FDA 510(k) clearance on 2022-09-01, under 510(k) number K220997.

Who is the listed applicant for Wireless TENS/EMS, Bruno, Aela?

The FDA 510(k) record lists Zmi Elecronics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wireless TENS/EMS, Bruno, Aela?

The FDA product code for Wireless TENS/EMS, Bruno, Aela is NUH.

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Dispositivos Relacionados (Código: NUH)

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Fonte oficial

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