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FDA 510(k)

UINCARE HOME

K-Number: K172882 · 2018-05-10

ApplicantUincare Corp.
Decision Date2018-05-10
Product CodeLXJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

UINCARE HOME is the device name listed in this FDA 510(k) record. The listed applicant is Uincare Corp.. It received FDA 510(k) clearance on 2018-05-10 under 510(k) number K172882. The device is classified under product code LXJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UINCARE HOME?

UINCARE HOME is a medical device that received FDA 510(k) clearance on 2018-05-10. The listed applicant is Uincare Corp.. The 510(k) number is K172882.

When did UINCARE HOME receive FDA 510(k) clearance?

UINCARE HOME received FDA 510(k) clearance on 2018-05-10, under 510(k) number K172882.

Who is the listed applicant for UINCARE HOME?

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

What is the FDA product code for UINCARE HOME?

The FDA product code for UINCARE HOME is LXJ.

Related Devices (Code: LXJ)

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.

K192474VERAReflexion Health, Inc.K182333VeraReflexion Health, Inc.K180880DARI HealthScientific Analytics, Inc.K171547Qualisys Clinical SystemQualisys ABK173931MindMotion(TM) GOMindmaze SAK162748MindMotionPROMindmaze SA

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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