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FDA 510(k)

AerFrame Patient Immobilization System (AFPIS)

K-Number: K260792 · 2026-05-08

ApplicantStabilix, LLC
Decision Date2026-05-08
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AerFrame Patient Immobilization System (AFPIS) is a medical device manufactured by Stabilix, LLC. It received FDA 510(k) clearance on 2026-05-08 under approval number K260792. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AerFrame Patient Immobilization System (AFPIS)?

AerFrame Patient Immobilization System (AFPIS) is a medical device that received FDA 510(k) clearance on 2026-05-08. It is manufactured by Stabilix, LLC. The 510(k) number is K260792.

When was AerFrame Patient Immobilization System (AFPIS) approved by the FDA?

AerFrame Patient Immobilization System (AFPIS) received FDA 510(k) clearance on 2026-05-08, under approval number K260792.

What company makes AerFrame Patient Immobilization System (AFPIS)?

AerFrame Patient Immobilization System (AFPIS) is manufactured by Stabilix, LLC.

What is the FDA product code for AerFrame Patient Immobilization System (AFPIS)?

The FDA product code for AerFrame Patient Immobilization System (AFPIS) is IYE.

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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