FDA 510(k)

Wrap Accessory Electrodes

Número K: K210383 · 2021-11-12

Data da decisão2021-11-12

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wrap Accessory Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Hi-Dow International, Inc.. It received FDA 510(k) clearance on 2021-11-12 under 510(k) number K210383. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Wrap Accessory Electrodes?

Wrap Accessory Electrodes is a medical device that received FDA 510(k) clearance on 2021-11-12. The listed applicant is Hi-Dow International, Inc.. The 510(k) number is K210383.

When did Wrap Accessory Electrodes receive FDA 510(k) clearance?

Wrap Accessory Electrodes received FDA 510(k) clearance on 2021-11-12, under 510(k) number K210383.

Who is the listed applicant for Wrap Accessory Electrodes?

The FDA 510(k) record lists Hi-Dow International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wrap Accessory Electrodes?

The FDA product code for Wrap Accessory Electrodes is GXY.

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Outros registros que listam Hi-Dow International, Inc. como candidato(a)

K233461Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)K202337Pulsed electromagnetic field wrap K190617Wrap accessory electrodes K163393Hi-Dow Wireless TENS/EMS System (Model HD-5N)

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Fonte oficial

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