FDA 510(k)

HPR45i

K-Number: K220725 · 2023-03-20

Decision Date2023-03-20

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HPR45i is a medical device manufactured by F Care Systems USA, LLC. It received FDA 510(k) clearance on 2023-03-20 under approval number K220725. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HPR45i?

HPR45i is a medical device that received FDA 510(k) clearance on 2023-03-20. It is manufactured by F Care Systems USA, LLC. The 510(k) number is K220725.

When was HPR45i approved by the FDA?

HPR45i received FDA 510(k) clearance on 2023-03-20, under approval number K220725.

What company makes HPR45i?

HPR45i is manufactured by F Care Systems USA, LLC.

What is the FDA product code for HPR45i?

The FDA product code for HPR45i is GEI.

Other Devices by F Care Systems USA, LLC

K210077MED RF 4000 K252704F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)

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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.