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FDA 510(k)

SilentZPro 2.0

K-Number: K220688 · 2022-12-02

ApplicantShinrin-Yoku Traders, LLC
Decision Date2022-12-02
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SilentZPro 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Shinrin-Yoku Traders, LLC. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K220688. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SilentZPro 2.0?

SilentZPro 2.0 is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Shinrin-Yoku Traders, LLC. The 510(k) number is K220688.

When did SilentZPro 2.0 receive FDA 510(k) clearance?

SilentZPro 2.0 received FDA 510(k) clearance on 2022-12-02, under 510(k) number K220688.

Who is the listed applicant for SilentZPro 2.0?

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

What is the FDA product code for SilentZPro 2.0?

The FDA product code for SilentZPro 2.0 is LRK.

Related Devices (Code: LRK)

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.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

Official Source

View on FDA Database →

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

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