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FDA 510(k)

Pure Tilt

K-Number: K152021 · 2016-03-31

ApplicantProactive Comfort, LLC
Decision Date2016-03-31
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Pure Tilt is a medical device manufactured by Proactive Comfort, LLC. It received FDA 510(k) clearance on 2016-03-31 under approval number K152021. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pure Tilt?

Pure Tilt is a medical device that received FDA 510(k) clearance on 2016-03-31. It is manufactured by Proactive Comfort, LLC. The 510(k) number is K152021.

When was Pure Tilt approved by the FDA?

Pure Tilt received FDA 510(k) clearance on 2016-03-31, under approval number K152021.

What company makes Pure Tilt?

Pure Tilt is manufactured by Proactive Comfort, LLC.

What is the FDA product code for Pure Tilt?

The FDA product code for Pure Tilt is IOR.

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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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