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FDA 510(k)

brAIn™ Shoulder Positioning

K-Number: K252665 · 2025-10-20

ApplicantAvatar Medical
Decision Date2025-10-20
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

brAIn™ Shoulder Positioning is a medical device manufactured by Avatar Medical. It received FDA 510(k) clearance on 2025-10-20 under approval number K252665. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the brAIn™ Shoulder Positioning?

brAIn™ Shoulder Positioning is a medical device that received FDA 510(k) clearance on 2025-10-20. It is manufactured by Avatar Medical. The 510(k) number is K252665.

When was brAIn™ Shoulder Positioning approved by the FDA?

brAIn™ Shoulder Positioning received FDA 510(k) clearance on 2025-10-20, under approval number K252665.

What company makes brAIn™ Shoulder Positioning?

brAIn™ Shoulder Positioning is manufactured by Avatar Medical.

What is the FDA product code for brAIn™ Shoulder Positioning?

The FDA product code for brAIn™ Shoulder Positioning is QIH.

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Other Devices by Avatar Medical

K222035Avatar Medical Software V1 K243292brAIn™ Shoulder Positioning K253950Avatar Medical Vision

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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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