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FDA 510(k)

PureLift

K-Number: K190269 · 2019-08-28

Decision Date2019-08-28
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PureLift is the device name listed in this FDA 510(k) record. The listed applicant is Xtreem Pulse, LLC. It received FDA 510(k) clearance on 2019-08-28 under 510(k) 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. The listed applicant is Xtreem Pulse, LLC. The 510(k) number is K190269.

When did PureLift receive FDA 510(k) clearance?

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

Who is the listed applicant for PureLift?

The FDA 510(k) record lists Xtreem Pulse, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PureLift?

The FDA product code for PureLift is NFO.

Other records listing Xtreem Pulse, LLC as applicant

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.

Related Devices (Code: NFO)

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.

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.