FDA 510(k)

REST EAZY Appliance

K-Number: K172760 · 2018-03-26

Decision Date2018-03-26

Product CodeLRK

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

REST EAZY Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Insert Molding Solutions, Inc.. It received FDA 510(k) clearance on 2018-03-26 under 510(k) number K172760. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REST EAZY Appliance?

REST EAZY Appliance is a medical device that received FDA 510(k) clearance on 2018-03-26. The listed applicant is Insert Molding Solutions, Inc.. The 510(k) number is K172760.

When did REST EAZY Appliance receive FDA 510(k) clearance?

REST EAZY Appliance received FDA 510(k) clearance on 2018-03-26, under 510(k) number K172760.

Who is the listed applicant for REST EAZY Appliance?

The FDA 510(k) record lists Insert Molding Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REST EAZY Appliance?

The FDA product code for REST EAZY Appliance is LRK.

Related Devices (Code: LRK)

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.

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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.