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FDA 510(k)

Soniquence Reusable 3 Button Fingerswitch Wand

K-Number: K212222 · 2022-09-02

ApplicantSoniquence, LLC
Decision Date2022-09-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Soniquence 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 2022-09-02 under 510(k) number K212222. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Soniquence Reusable 3 Button Fingerswitch Wand?

Soniquence Reusable 3 Button Fingerswitch Wand is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Soniquence, LLC. The 510(k) number is K212222.

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

Soniquence Reusable 3 Button Fingerswitch Wand received FDA 510(k) clearance on 2022-09-02, under 510(k) number K212222.

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

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

Other records listing Soniquence, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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