Reminder, Medication

Device Code: 2800

Product Code(s): NXQ

Definition: A Medication Reminder Is A Device Intended For Medical Purposes To Provide Alerts To Patients Or Healthcare Providers For Pre-determined Medication Dosing Schedules. The Device May Incorporate Wireless Communication.

Device Classification Information

Device Type ID2800
Device NameReminder, Medication
Physical StateThe Device Size Can Range From A Handheld Device To That Of A Desk Or Countertop Device.
Technical MethodThe Device Is Electrically-powered, Either Battery Or AC, And May Incorporate Wireless Technology.
Target AreaTarget Area Depends On Intended Target Area Of The Drug Or Drugs Taken By The Patient.
Regulation DescriptionDaily Activity Assist Device.
Regulation Medical SpecialtyPhysical Medicine
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(K) Exempt
CFR Regulation Number890.5050 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNXQ
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2800
DeviceReminder, Medication
Product CodeNXQ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDaily Activity Assist Device.
CFR Regulation Number890.5050 [🔎]
Device Problems
Material Perforation
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 20:19:02

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