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FDA 510(k)

FA100 SCCD (Sequential Continuous Contraction Device)

K-Number: K162987 · 2017-02-14

ApplicantFlowaid Medical Technologies, Corp
Decision Date2017-02-14
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FA100 SCCD (Sequential Continuous Contraction Device) is a medical device manufactured by Flowaid Medical Technologies, Corp. It received FDA 510(k) clearance on 2017-02-14 under approval number K162987. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FA100 SCCD (Sequential Continuous Contraction Device)?

FA100 SCCD (Sequential Continuous Contraction Device) is a medical device that received FDA 510(k) clearance on 2017-02-14. It is manufactured by Flowaid Medical Technologies, Corp. The 510(k) number is K162987.

When was FA100 SCCD (Sequential Continuous Contraction Device) approved by the FDA?

FA100 SCCD (Sequential Continuous Contraction Device) received FDA 510(k) clearance on 2017-02-14, under approval number K162987.

What company makes FA100 SCCD (Sequential Continuous Contraction Device)?

FA100 SCCD (Sequential Continuous Contraction Device) is manufactured by Flowaid Medical Technologies, Corp.

What is the FDA product code for FA100 SCCD (Sequential Continuous Contraction Device)?

The FDA product code for FA100 SCCD (Sequential Continuous Contraction Device) is IPF.

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Related PubMed Literature

PMID: 41647013 Deficiencies of the EU Medical Device Regulation when applying its own rules. Frontiers in medicine (2025)

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Official Source

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