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FDA 510(k)

PureLift

K-Number: K190269 · 2019-08-28

ApplicantXtreem Pulse, LLC
Decision Date2019-08-28
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PureLift is a medical device manufactured by Xtreem Pulse, LLC. It received FDA 510(k) clearance on 2019-08-28 under approval number K190269. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PureLift?

PureLift is a medical device that received FDA 510(k) clearance on 2019-08-28. It is manufactured by Xtreem Pulse, LLC. The 510(k) number is K190269.

When was PureLift approved by the FDA?

PureLift received FDA 510(k) clearance on 2019-08-28, under approval number K190269.

What company makes PureLift?

PureLift is manufactured by Xtreem Pulse, LLC.

What is the FDA product code for PureLift?

The FDA product code for PureLift is NFO.

Other Devices by Xtreem Pulse, LLC

K173483Pure Flow External Counter-Pulsation Device K221443PureLift Pro Plus K243587PureLift GLOW

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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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