Citizen Petition

September 21, 2015 – On September 14, 2015, INRange Systems, Inc. (“INRange”), a specialty healthcare company which manufactures medication management systems, filed a petition requesting the FDA detain a product offering labeled “LUMMA” sold by Life Integrating Technologies and Experience, Inc.  The petition describes LUMMA as a “Remote Medication Management System” which is subject to FDA regulation.  INRange argues that the LUMMA device is an unapproved and misbranded device as it has the same intended functions and intended use as generic devices of the type classified as “Remote Medication Management Systems” and is subject to requirements for establishment registration, device listing and premarket notification as set forth in 21 C.F.R. Section 880.6315.  As a result, INRange requests the FDA seize all existing models of the LUMMA device presently on the market and enjoin the parties presently manufacturing or selling the LUMMA device from continuing to market the device.

By:  Ketan V. Patel

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