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FDA 510(k)

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub

K-Number: K190073 · 2019-03-27

ApplicantCurrent Health , Ltd.
Decision Date2019-03-27
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub is a medical device manufactured by Current Health , Ltd.. It received FDA 510(k) clearance on 2019-03-27 under approval number K190073. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub?

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub is a medical device that received FDA 510(k) clearance on 2019-03-27. It is manufactured by Current Health , Ltd.. The 510(k) number is K190073.

When was Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub approved by the FDA?

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub received FDA 510(k) clearance on 2019-03-27, under approval number K190073.

What company makes Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub?

Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub is manufactured by Current Health , Ltd..

What is the FDA product code for Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub?

The FDA product code for Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub is MSX.

Related Clinical Trials

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Related PubMed Literature

PMID: 41613162 Evaluating Translational AI: A Two-Way Moving Target Problem. NEJM AI (2025) PMID: 41572440 Regulating Medical Devices: The Values and Politics of the US FDA Review Process. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 40020872 Biosensors in wearable medical devices: Regulatory framework and compliance across US, EU, and Indian markets. Annales pharmaceutiques francaises (2025) PMID: 39396094 A scoping review on advancements in noninvasive wearable technology for heart failure management. NPJ digital medicine (2024)

Other Devices by Current Health , Ltd.

K191272Wearable Device, Wearable Package K222550Current Health System K231506Current Health System

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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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