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510(k) Data Aggregation
K Number
K103009Device Name
SENTICARE PILLSTATION
Manufacturer
SENTICARE, INC.
Date Cleared
2011-01-28
(108 days)
Product Code
NXQ
Regulation Number
890.5050Why did this record match?
Product Code :
NXQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SentiCare PillStation is intended for medical purposes to provide alerts to patients and healthcare providers for pre-determined medication dosing schedules. The device incorporates wireless communication and electronic imaging.
Device Description
The SentiCare PillStation includes an electronic pillbox for home use (the PillStation), and server software for communicating and programming the PillStation (PillStation Manager Software). The SentiCare PillStation is designed to assist individuals with medication organization, self administration, and adherence. Specifically, the PillStation is designed to aid individuals in medication organization and reconciliation: identify incomplete or inappropriate removal of medications with corrective feedback; teach and coach about medications and daily medical procedures; provide alerts of dose times; and ensure timely relills of all medications self-administration. The SentiCare PillStation is a daily assist device with many features to alert users and caregivers of pre-determined scheduled medication times: easy to use pill tray, pill bins highlighted by light-up indicators, pill alarms, and LCD serven messaging. Through PillStation's built in scanning system, high quality, static digital images are sent from the PillStation to PillStation Manager software. Remote monitors, are other alled "Call Center Advisors", monitor and verify PillStation's medication contents with PillStation users' prescriptions in order to keep track of medication aterts and verify that the user and/or caregiver has loaded their prescribed medications into the PillStation pill tray. This monitoring is accomplished through the PillStation Manager software. The SentiCare PillStation is a novel approach to medication organization and may be of great assistance to those individuals and caregivers who look to improve upon their own medication organization, adherence, and self administration.
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K Number
K060298Device Name
PILL PHONE
Manufacturer
VOCEL
Date Cleared
2006-03-29
(51 days)
Product Code
NXQ, MED
Regulation Number
890.5050Why did this record match?
Product Code :
NXQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PILL PHONE is a medication reminder and information system utilizing software that operates on a user's cell phone or other wireless device. The PILL PHONE will also have the ability to receive multiple question surveys from the PILL PHONE server.
Device Description
The PILL PHONE software device will be sold to users of cell phones (or other communication devices) through their cell phone service. The software will have a feature to send out reminders to a cell phone owner of the dosing schedule that has been programmed into the phone, whether the dosing schedule is for the user, a child, or an elderly parent. The software will also enable the delivery of information about medications, such as indications for use, dosing, side effects, and even photographs of different pills. The PILL PHONE software is a Minor Level of Concern.
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