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FDA 510(k)

Primary Relief

K-Number: K221425 · 2022-09-13

ApplicantDyansys, Inc.
Decision Date2022-09-13
Product CodeNHI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Primary Relief is a medical device manufactured by Dyansys, Inc.. It received FDA 510(k) clearance on 2022-09-13 under approval number K221425. The device is classified under product code NHI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Primary Relief?

Primary Relief is a medical device that received FDA 510(k) clearance on 2022-09-13. It is manufactured by Dyansys, Inc.. The 510(k) number is K221425.

When was Primary Relief approved by the FDA?

Primary Relief received FDA 510(k) clearance on 2022-09-13, under approval number K221425.

What company makes Primary Relief?

Primary Relief is manufactured by Dyansys, Inc..

What is the FDA product code for Primary Relief?

The FDA product code for Primary Relief is NHI.

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Other Devices by Dyansys, Inc.

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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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