biointellisense.comBioButton System
Biointellisense, Inc.
BIOINTELLISENSE INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016592682 | 3016592682 | BIOINTELLISENSE INC. | 1 | N | 2026-01-01 | 805 Veterans Blvd UNIT 105 Redwood City CA US 94063 |
| 3017986070 | 3017986070 | BIOINTELLISENSE INC. | 1 | Y | 2026-01-01 | 17301 W. Colfax Ave. Suite 152 Golden CO US 80401 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850005949466 | 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. | +1 888-908-8804 | support@biointellisense.com |
| 00850005949558 | 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. | +1 888-908-8804 | support@biointellisense.com |
| 00850005949565 | 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. | +1 888-908-8804 | support@biointellisense.com |
| 00850005949596 | BioButton 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. | +1 888-908-8804 | support@biointellisense.com |
| 00850005949671 | BioButton 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. | +1 888-908-8804 | support@biointellisense.com |
| 10850005949555 | 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. | +1 888-908-8804 | support@biointellisense.com |
| 10850005949562 | 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. | +1 888-908-8804 | support@biointellisense.com |
| 10850005949593 | BioButton 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. | +1 888-908-8804 | support@biointellisense.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 239098 | 1081112677 | K241101 | BioButton System | DRG | 2024-09-26 |
| 306265 | 1081112677 | K241101 | BioButton System | DRG | 2024-09-26 |
| 239098 | 1717072602 | K212957 | BioButton System | DRG | 2022-12-12 |
| 306265 | 1717072602 | K212957 | BioButton System | DRG | 2022-12-12 |
| 239098 | 1289220509 | K191614 | BioSticker System | DRG | 2019-12-18 |
| 306265 | 1289220509 | K191614 | BioSticker System | DRG | 2019-12-18 |
| 239098 | 1414831568 | ||||
| 306265 | 1414831568 | ||||
| 239098 | 1806717086 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DRG | 6 | 2024-09-26 |
PMN#
BioSticker System
BioIntelliSense Inc.
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.
2025-02-28
BioButton 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.
2025-11-19
BioButton 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.
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.
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.
2025-02-19
BioButton 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.
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.
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.
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.
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.
2025-02-11
BioButton Adhesive V2 (ADH-CS) - BioButton Cold Seal Adhesive V2 (ADH-CS)
2024-05-01
BioButton Adhesive V2 (ADH-CS) - BioButton Cold Seal Adhesive V2 (ADH-CS)
2024-05-01
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
2023-07-03
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
2023-09-05
BioButton Rechargeable Adhesives (ADD-HT) - Adhesive accessory packs for wearable devices - 5 pcs, ADD, HT; SKU: ADH-AC1-BBR-5-1-1-10
2022-07-20
BioButton At-Home Kit with Power Adaptor and Adhesives - KIT-BBR-3763-5
2023-11-16
BioButton At-Home Kit - KIT-BBR-3763-2
2023-11-16
BioButton At-Home Kit with Adhesives and BioButton - KIT-BBR-3763-4
2023-11-16
BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton - KIT-BBR-3763-3
2023-11-16
BioButton At-Home Kit with Power Adaptor - KIT-BBR-3763-1
2023-11-16
BioButton At-Home Kit with Power Adaptor and Adhesives - KIT-BBR-3763-5
2023-11-16
BioButton At-Home Kit - KIT-BBR-3763-2
2023-11-16
BioButton At-Home Kit with Adhesives and BioButton - KIT-BBR-3763-4
2023-11-16
BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton - KIT-BBR-3763-3
2023-11-16
BioButton At-Home Kit with Power Adaptor - KIT-BBR-3763-1
2023-11-16
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.
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.
2023-09-28
BioButton v3 (BBN-r) - 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.
2021-12-17
BioButton Rechargeable Adhesives (ADD-HT) - Adhesive accessory packs for wearable devices - 5 pcs, ADD, HT; SKU: ADH-AC1-BBR-5-1-1-10
2022-07-20
BioButton Rechargeable Adhesives - Adhesive accessory packs for wearable devices (OMI, ADB); ACCS-1-ST06-1-4
2022-03-01
BioButton v2 - 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.
2021-04-23
BioButton - 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.
2020-11-09
BioButton Rechargeable Adhesives - Adhesive accessory packs for wearable devices
2022-03-01
BioButton v3 (BBN-r) - 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.
2021-12-17
BioButton v2 - 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.
2021-04-23
BioButton - 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.
2020-11-09
BioSticker™ - The BioSticker™ System is a wearable remote monitoring system intended for continuous collection of physiological data in home and healthcare settings.
2020-05-01
BioSticker™ System Offload Software - Offload Software for the BioSticker System.
2020-05-01