FDA 510(k)

Lower Limb AI (LLAI)

K-Number: K261641 · 2026-08-18

Decision Date2026-08-18

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Lower Limb AI (LLAI) is the device name listed in this FDA 510(k) record. The listed applicant is AI Planning Logic, Inc.. It received FDA 510(k) clearance on 2026-08-18 under 510(k) number K261641. 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 Lower Limb AI (LLAI)?

Lower Limb AI (LLAI) is a medical device that received FDA 510(k) clearance on 2026-08-18. The listed applicant is AI Planning Logic, Inc.. The 510(k) number is K261641.

When did Lower Limb AI (LLAI) receive FDA 510(k) clearance?

Lower Limb AI (LLAI) received FDA 510(k) clearance on 2026-08-18, under 510(k) number K261641.

Who is the listed applicant for Lower Limb AI (LLAI)?

The FDA 510(k) record lists AI Planning Logic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lower Limb AI (LLAI)?

The FDA product code for Lower Limb AI (LLAI) is QIH.

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Official Source

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