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FDA 510(k)

maiLink

K-Number: K253008 · 2026-01-05

ApplicantMaihub Corp.
Decision Date2026-01-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

maiLink is the device name listed in this FDA 510(k) record. The listed applicant is Maihub Corp.. It received FDA 510(k) clearance on 2026-01-05 under 510(k) number K253008. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the maiLink?

maiLink is a medical device that received FDA 510(k) clearance on 2026-01-05. The listed applicant is Maihub Corp.. The 510(k) number is K253008.

When did maiLink receive FDA 510(k) clearance?

maiLink received FDA 510(k) clearance on 2026-01-05, under 510(k) number K253008.

Who is the listed applicant for maiLink?

The FDA 510(k) record lists Maihub Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for maiLink?

The FDA product code for maiLink is LLZ.

Related Devices (Code: LLZ)

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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