FDA.report

Ambulatory fall sensor

Definition
A battery-powered electronic device intended to be worn on a patient’s body (e.g., in the form of a patch, pendant, wristband) to provide an alert signal for help when automatically activated in response to an event requiring need for assistance or care, typically in cases of falls or epileptic seizures. It consists of a sensor with a wireless radio-frequency transmitter which activates a nurse call or home alert system communication device (e.g., phone, pager) to notify a medical professional, caregiver, neighbour, or emergency medical services (EMS) that urgent assistance is needed. It is intended to be used in the home and healthcare facility.
GUDID devices
30
Last updated
2024-11-06 08:27:41

Related Product Codes

CodeDeviceSpecialtyClassDevices
KMIMonitor, Bed PatientGeneral Hospital129
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00840948103285Securitas HealthcareSecuritas Healthcare LLC750002024-10-29
00840948103292Securitas HealthcareSecuritas Healthcare LLC750012024-10-29
00840948103308Securitas HealthcareSecuritas Healthcare LLC750022024-10-29
00840948103315Securitas HealthcareSecuritas Healthcare LLC740102024-10-29
00840948103322Securitas HealthcareSecuritas Healthcare LLC740112024-10-29
00840117334441Dynarex Protech Mobile MonitorDYNAREX CORPORATIONP-8002002021-04-22
00843997012409CentroidMASIMO CORPORATION43022023-08-22
00840117322998Dynarex Protech Flex MonitorDYNAREX CORPORATIONP-8003002021-04-22
00840117323025Dynarex Protech Voice MonitorDYNAREX CORPORATIONP-8004002021-04-22
00840117323056Dynarex Protech Ultra MonitorDYNAREX CORPORATIONP-8009002021-04-22
00840117322936Dynarex Protech String Fall MonitorDYNAREX CORPORATIONP-8001002021-04-22
00840948102516CHAIR PAD, 7x15, 14-DAY, 8FTSTANLEY SECURITY SOLUTIONS, INC.730302022-08-08
00812293015124Smart CaregiverSmart Caregiver CorporationTM-FM2022-06-10
00812293015131Smart CaregiverSmart Caregiver CorporationTM-SMS2022-06-10
00812293016091Smart CaregiverSmart Caregiver CorporationTM-12B2022-06-10
00812293016107Smart CaregiverSmart Caregiver CorporationTM-12C2022-06-10
00812293010662Smart CaregiverSmart Caregiver CorporationTL-2012SR12022-05-31
00812293015766Smart CaregiverSmart Caregiver CorporationPT-012022-05-26
00812293015902Smart CaregiverSmart Caregiver CorporationPT-FM2022-05-26
00812293016367Smart CaregiverSmart Caregiver CorporationDTPC-TM2022-05-23
00812293010563Smart CaregiverSmart Caregiver Corporation433-EXT2022-05-19
00840948101106CHAIR PAD, 7x15, 14-DAY, 8FT, ANTI-SLIPSTANLEY SECURITY SOLUTIONS, INC.73030AS2021-07-29
00840948101267SENSOR SELECT,MONTIOR/2 PAD ADAPTORSTANLEY SECURITY SOLUTIONS, INC.720902021-07-29
00840948101274CHAIR PAD, 7x15, 90-DAY, 8FT, TABSSTANLEY SECURITY SOLUTIONS, INC.260002021-07-29
10840948101295BED PAD,45DAY,6 PACK,BSM-1W-6STANLEY SECURITY SOLUTIONS, INC.950802021-07-15
00840117319981Dynarex Protech String MonitorDYNAREX CORPORATIONP-8001002021-04-22
00840117319998Dynarex Protech Mobile MonitorDYNAREX CORPORATIONP-8002002021-04-22
00840117320000Dynarex Protech Flex MonitorDYNAREX CORPORATIONP-8003002021-04-22
00840117320017Dynarex Protech Voice MonitorDYNAREX CORPORATIONP-8004002021-04-22
00840117320024Dynarex Protech Ultra MonitorDYNAREX CORPORATIONP-8009002021-04-22