FDA.reportPublic FDA data

BIOINTELLISENSE INC.

Matched from indexed company URL: Biointellisense, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30165926823016592682BIOINTELLISENSE INC.1N2026-01-01805 Veterans Blvd UNIT 105 Redwood City CA US 94063
30179860703017986070BIOINTELLISENSE INC.1Y2026-01-0117301 W. Colfax Ave. Suite 152 Golden CO US 80401

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850005949466BioDashboard - BioDashboard, as part of the FDA-cleared BioButton System, is intended to display and visualize physiological and medical data and log assessments. The Device displays data and notifies healthcare professionals when physiological data fall outside clinician specified parameters. The data from the Device are intended as an aid to diagnosis, diseases management, and treatment. The Device has the ability to allow the clinician to configure the parameters for notifications.Healthcare professionals are the intended operators of this device. The Device is intended for use on patients who are 18 years of age or older. The Device is not intended for critical care.+1 888-908-8804support@biointellisense.com
00850005949558BioButton (Reprocessed) - The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients.Note: this model is reprocessed device.+1 888-908-8804support@biointellisense.com
00850005949565BioButton (Reprocessed, NF Version) - The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients.Note: this model is reprocessed device.+1 888-908-8804support@biointellisense.com
00850005949596BioButton Charging Station - The BioButton Charging Station is intended to be used by trained professionals to charge multiple compatible rechargeable wearable devices simultaneously in healthcare or other care facilities.The charger is not intended to be used at the patient home.+1 888-908-8804support@biointellisense.com
00850005949671BioButton Charging Station - The BioButton Charging Station is intended to be used by trained professionals to charge multiple compatible rechargeable wearable devices simultaneously in healthcare or other care facilities.The charger is not intended to be used at the patient home.This UDI is for Gen 2 design.+1 888-908-8804support@biointellisense.com
10850005949555BioButton (Reprocessed) - The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data. The device is intended for use on users who are 18 years of age or older. The device does not output heart rate or respiratory rate measurements during periods of motion or activity. The device is not intended for use on critical care patients. Note: this model is reprocessed device.+1 888-908-8804support@biointellisense.com
10850005949562BioButton (Reprocessed, NF Version) - The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data. The device is intended for use on users who are 18 years of age or older. The device does not output heart rate or respiratory rate measurements during periods of motion or activity. The device is not intended for use on critical care patients. Note: this model is reprocessed device.+1 888-908-8804support@biointellisense.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2390981081112677K241101BioButton SystemDRG2024-09-26
3062651081112677K241101BioButton SystemDRG2024-09-26
2390981717072602K212957BioButton SystemDRG2022-12-12
3062651717072602K212957BioButton SystemDRG2022-12-12
2390981289220509K191614BioSticker SystemDRG2019-12-18
3062651289220509K191614BioSticker SystemDRG2019-12-18
2390981414831568
3062651414831568
2390981806717086

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DRG62024-09-26

PMN#

GUDID#

BioDashboard - BioDashboard, as part of the FDA-cleared BioButton System, is intended to display and visualize physiological and medical data and log assessments. The Device displays data and notifies healthcare professionals when physiological data fall outside clinician specified parameters. The data from the Device are intended as an aid to diagnosis, diseases management, and treatment. The Device has the ability to allow the clinician to configure the parameters for notifications.Healthcare professionals are the intended operators of this device. The Device is intended for use on patients who are 18 years of age or older. The Device is not intended for critical care.

BIOINTELLISENSE, INC.

2025-02-28

BioButton (Reprocessed) - The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients.Note: this model is reprocessed device.

BIOINTELLISENSE, INC.

2025-02-19

BioButton (Reprocessed, NF Version) - The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients.Note: this model is reprocessed device.

BIOINTELLISENSE, INC.

2025-02-19

BioButton (Reprocessed) - The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data. The device is intended for use on users who are 18 years of age or older. The device does not output heart rate or respiratory rate measurements during periods of motion or activity. The device is not intended for use on critical care patients. Note: this model is reprocessed device.

BIOINTELLISENSE, INC.

2025-02-19

BioButton (Reprocessed, NF Version) - The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data. The device is intended for use on users who are 18 years of age or older. The device does not output heart rate or respiratory rate measurements during periods of motion or activity. The device is not intended for use on critical care patients. Note: this model is reprocessed device.

BIOINTELLISENSE, INC.

2025-02-19

BioButton Rechargeable Device, Multi-Patient - The BioButton System (Multi-patient) is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other data such as activity level, body position, sleep, and step and gait analysis.Data are securely transmitted via wireless connection for storage, review, analysis, and display. The Device can include the ability to display data and notify healthcare professionals when physiological data fall outside clinician-specified parameters.The data from the Device are intended as an aid to diagnosis, disease management, and treatment. The Device is intended for use on patients who are 18 years of age or older.The Device is not intended to output physiological measurements while the patient undergoes significant motion or is active.The Device is not intended for critical care.This Device is cleared in K241101 to be reprocessed and reused.

BIOINTELLISENSE, INC.

2025-02-11

BioButton Rechargeable Device, Multi-Patient - The BioButton System (Multi-patient) is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other data such as activity level, body position, sleep, and step and gait analysis. Data are securely transmitted via wireless connection for storage, review, analysis, and display. The Device can include the ability to display data and notify healthcare professionals when physiological data fall outside clinician-specified parameters. The data from the Device are intended as an aid to diagnosis, disease management, and treatment. The Device is intended for use on patients who are 18 years of age or older. The Device is not intended to output physiological measurements while the patient undergoes significant motion or is active. The Device is not intended for critical care. This Device is cleared in K241101 to be reprocessed and reused.

BIOINTELLISENSE, INC.

2025-02-11

BioButton v3 (BBN-r, different batch) - Note: 00850005949299 (Model# BIOST06040) is equivalent to BBN-r (BBN v3) (01) 00850005949183 (Model# BIOST06040F), coming from different production batches and with a different model#. The intended use is identical to 00850005949183: The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients.P/N: BBR-B-NF-I-N

BIOINTELLISENSE, INC.

2023-09-05

BioButton (In Bulk Packaging) - The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients.P/N: BBR-B-I-N

BIOINTELLISENSE, INC.

2023-07-03

BioButton v3 (BBN-r, different batch, Individual Pack) - Note: 00850005949220 (Model# BIOST06040) is equivalent to BBN-r (BBN v3) (01) 00850005949183 (Model# BIOST06040F), coming from different production batches and with a different model#. The intended use is identical to 00850005949183: The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.The device is intended for use on users who are 18 years of age or older.The device does not output heart rate or respiratory rate measurements during periods of motion or activity.The device is not intended for use on critical care patients.

BIOINTELLISENSE, INC.

2023-09-28

BioButton v3 (BBN-r, different batch, Individual Pack) - Note: 00850005949220 (Model# BIOST06040) is equivalent to BBN-r (BBN v3) (01) 00850005949183 (Model# BIOST06040F), coming from different production batches and with a different model#. The intended use is identical to 00850005949183: The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data. The device is intended for use on users who are 18 years of age or older. The device does not output heart rate or respiratory rate measurements during periods of motion or activity. The device is not intended for use on critical care patients.

BIOINTELLISENSE, INC.

2023-09-28