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FDA 510(k)

Prelivia

K-Number: K210979 · 2021-05-13

ApplicantRehabtronics, Inc.
Decision Date2021-05-13
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Prelivia is a medical device manufactured by Rehabtronics, Inc.. It received FDA 510(k) clearance on 2021-05-13 under approval number K210979. 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 Prelivia?

Prelivia is a medical device that received FDA 510(k) clearance on 2021-05-13. It is manufactured by Rehabtronics, Inc.. The 510(k) number is K210979.

When was Prelivia approved by the FDA?

Prelivia received FDA 510(k) clearance on 2021-05-13, under approval number K210979.

What company makes Prelivia?

Prelivia is manufactured by Rehabtronics, Inc..

What is the FDA product code for Prelivia?

The FDA product code for Prelivia is IPF.

Other Devices by Rehabtronics, Inc.

K153163ReGrasp

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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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