NZH

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Medication Management System, Remote

Device class

Class II (moderate risk)

Regulation

21 CFR 880.6315

Medical specialty

General Hospital

FDA definition

A remote medication management system provides a means for the patient's prescribed medications to be stored in a delivery unit; For a medical provider to remotely schedule the patient's prescribed medications; To provide notification to 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 provide to the medical provider a history of the event. The system is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic.

Adverse events (MAUDE)

2008: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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