FDA 510(k)

Reusable 3 Button Fingerswitch Wand

Número K: K254220 · 2026-01-27

Data da decisão2026-01-27

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Reusable 3 Button Fingerswitch Wand is the device name listed in this FDA 510(k) record. The listed applicant is Soniquence, LLC. It received FDA 510(k) clearance on 2026-01-27 under 510(k) number K254220. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Reusable 3 Button Fingerswitch Wand?

Reusable 3 Button Fingerswitch Wand is a medical device that received FDA 510(k) clearance on 2026-01-27. The listed applicant is Soniquence, LLC. The 510(k) number is K254220.

When did Reusable 3 Button Fingerswitch Wand receive FDA 510(k) clearance?

Reusable 3 Button Fingerswitch Wand received FDA 510(k) clearance on 2026-01-27, under 510(k) number K254220.

Who is the listed applicant for Reusable 3 Button Fingerswitch Wand?

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

What is the FDA product code for Reusable 3 Button Fingerswitch Wand?

The FDA product code for Reusable 3 Button Fingerswitch Wand is GEI.

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Outros registros que listam Soniquence, LLC como candidato(a)

K212222Soniquence Reusable 3 Button Fingerswitch Wand K220071Soniquence Reusable Neutral Plate K211946Soniquence Reusable Bipolar Cable K190336Soniquence Bipolar Electrodes K183611Soniquence RF Generator and Soniquence Electrodes

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Fonte oficial

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