This is a brief overview of information related to FDA’s approval of an Evaluation of Automatic Class III Designation to market this device.
Product Name: INRange Remote Medication Management System
Manufacturer: INRange Systems, Incorporated
Address: 220 Lakemont Park Boulevard, Altoona, PA 16602
Approval Date: June 13, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K051338.pdf
What is it? The INRange Remote Medication Management System is composed of clinical and communications software, a medication delivery unit, and medication packaging. The system is intended for use under the supervision of a licensed healthcare practitioner to remotely deliver, manage, assess, alter dosing schedules, and/or monitor a patient’s therapeutic medication regimens and adherence to those regimens in an outpatient setting.
How does it work? The INRange Remote Medication Management System provides a means:
- to store the patient's prescribed medications in a delivery unit
- for a healthcare professional to remotely schedule the patient's prescribed medications
- to notify the patient when the prescribed medications are due to be taken
- to release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command, and
- to record a history of the event for the healthcare professional
When is it used? The INRange Remote Medication Management System is used by healthcare professionals to aid in the control of the delivery of prescription drugs to patients in an outpatient setting.
What will it accomplish? The INRange Remote Medication Management System could help with outpatient adherence to complex medication regimens.
When should it not be used? There are no contraindications for this device.
510(k) Decision Summary and labeling will be available at: http://www.accessdata.fda.gov/cdrh_docs/pdf5/K051338.pdf