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FDA 510(k)

ActiveCare Home

K-Number: K160431 · 2016-07-13

ApplicantMedical Compression Systems (Dbn) , Ltd.
Decision Date2016-07-13
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ActiveCare Home is a medical device manufactured by Medical Compression Systems (Dbn) , Ltd.. It received FDA 510(k) clearance on 2016-07-13 under approval number K160431. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ActiveCare Home?

ActiveCare Home is a medical device that received FDA 510(k) clearance on 2016-07-13. It is manufactured by Medical Compression Systems (Dbn) , Ltd.. The 510(k) number is K160431.

When was ActiveCare Home approved by the FDA?

ActiveCare Home received FDA 510(k) clearance on 2016-07-13, under approval number K160431.

What company makes ActiveCare Home?

ActiveCare Home is manufactured by Medical Compression Systems (Dbn) , Ltd..

What is the FDA product code for ActiveCare Home?

The FDA product code for ActiveCare Home is JOW.

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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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