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510(k) Data Aggregation

    K Number
    K251114
    Device Name
    FloPatch FP120
    Manufacturer
    Flosonics Medical
    Date Cleared
    2025-06-20

    (70 days)

    Product Code
    DPW
    Regulation Number
    870.2100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in peripheral vasculature. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode only. The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use on adults only.
    Device Description
    The FloPatch (FP120) is a non-invasive blood flow detection device to be used in a medical/hospital setting for use by a medical professional. The device uses ultrasound and the Doppler effect to assess the flow of blood. The device consists of a signal processing unit and an adhesive strap. The device transmits ultrasonic waves from the ultrasonic transducer to a peripheral vessel. The Doppler shifted ultrasonic waves are reflected by moving blood cells back to the ultrasonic flow transducer. The reflected signal is received by the signal processing unit which outputs the Doppler signal wirelessly to a mobile medical application. The mobile medical application then processes the Doppler signal and displays a Max Velocity trace, Max VTI (Velocity Time Integral) and the Corrected Flow Time.
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    K Number
    K243852
    Device Name
    Elfor-L
    Manufacturer
    Elfi-Tech Ltd.
    Date Cleared
    2025-04-14

    (119 days)

    Product Code
    DPW
    Regulation Number
    870.2100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Elfor L is intended for measuring micro-vascular perfusion in skin and muscle in humans. It is intended to be used for clinical research applications and pre clinical research applications.
    Device Description
    The Elfor-L device is making use of Miniaturized Dynamic Light Scattering (mDLS) technology to non-invasively measure micro-vascular perfusion in the skin. The device is comprised of sensor and signal processing station. The device uses Vertical-Cavity Surface-Emitting Lasers (VCSEL) as the light source and two photodetectors for detection. The Elfor-L design incorporates three major components: 1. Sensor - the sensor as its predicate includes a laser light source and two photo sensitive elements. The sensor transfers analog signal to the control unit. 2. Control unit - the control unit is connected to the sensor by cable and includes the control circuit for the sensor, microcontroller and communication interface for the PC. 3. Dedicated software that processes, displays and record data on the computer. The computer is not part of the system.
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    K Number
    K242487
    Device Name
    Laminar P1 (LDH-HW-001)
    Manufacturer
    Laminar Digital Health, Inc.
    Date Cleared
    2024-12-13

    (114 days)

    Product Code
    JAF, DPW
    Regulation Number
    892.1540
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laminar P1 device is a wearable and disposable, ultrasound-based (4.5 MHz, continuous-wave) patch sensor designed to detect blood flow in peripheral vessels and assist in the detection of peripheral vascular disease. The Laminar P1 device is intended to be used by medical professionals, such as physicians and nurses, in hospitals, clinics and private offices and healthcare facilities. It is to be used on adults, ages 18 years and older.
    Device Description
    The Laminar P1 is an ultrasound-based battery-powered sensor patch designed to detect blood flow in veins and arteries to assist in the detection of peripheral vascular disease. The Laminar P1 consists of a single use sensor patch, a single use patch frame, and a reusable processing unit. The sensor patch is designed to have the same performance characteristics as traditional ultrasound transducer probes (4.5 MHz frequency) but in a patch form factor that is easy to place on the patient's body for a given time period. The patch frame is a sticky frame that aids in the positioning and alignment of the processing unit. The processing unit controls the piezoelectric transducers in the sensor patch and has a built-in speaker with volume-control, like the traditional handheld Doppler devices, and operates in the Doppler continuous-wave mode (4.5 MHz frequency). The Processing Unit is battery-operated.
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    K Number
    K241583
    Device Name
    VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)
    Manufacturer
    Remington Medical, Inc.
    Date Cleared
    2024-08-30

    (88 days)

    Product Code
    DPW
    Regulation Number
    870.2100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VascuChek® Kit, VascuChek® Transceiver, VascuChek® Clinical Probe, VascuChek® Charger: The VascuChek® device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature. VascuChek® Kit, VascuChek® Transceiver, VascuChek® Surgical Probe, VascuChek® Charger: The VascuChek® device is intended for the intraoperative and transcutaneous evaluation of blood flow in the following clinical applications: - Intraoperative (Microvascular and Vascular) - Intraoperative Neurological - Transrectal and Peripheral Vascular.
    Device Description
    VascuChek® Surgical is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field. VascuChek® Clinical is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field. The VascuChek® device follows Track 1. A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receives to a receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.
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    K Number
    K223843
    Device Name
    FloPatch FP120
    Manufacturer
    Flosonics Medical
    Date Cleared
    2023-05-03

    (132 days)

    Product Code
    DPW
    Regulation Number
    870.2100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in the carotid artery. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode, and is not capable of operating in any other mode. The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use on adults only.
    Device Description
    The FloPatch (FP120) is a non-invasive blood flow detection device to be used in a medical/hospital setting for use by a medical professional. The device uses ultrasound and the Doppler effect to assess the flow of blood. The device consists of a signal processing unit and an adhesive strap. The device transmits ultrasonic waves from the ultrasonic transducer to a peripheral vessel such as the carotid artery. The Doppler shifted ultrasonic waves are reflected by moving blood cells back to the ultrasonic flow transducer. The reflected signal is received by the signal processing unit which outputs the Doppler signal wirelessly to a mobile medical application. The mobile medical application then processes the Doppler signal and displays a Max Velocity trace, Max VTI (Velocity Time Integral) and the Corrected Flow Time.
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    K Number
    K222242
    Device Name
    FloPatch FP120
    Manufacturer
    Flosonics Medical
    Date Cleared
    2022-12-09

    (136 days)

    Product Code
    DPW
    Regulation Number
    870.2100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FloPatch FP120 is indicated for use for the noninvasive assessment of blood flow in the carotid artery. FloPatch FP120 operates in a single mode, the Continuous Wave (CW) mode, and is not capable of operating in any other mode. The device is intended to be used by medical professionals, such as physicians and nurses, in hospitals and professional environments. The device is intended for prescription use on adults only.
    Device Description
    The FloPatch (FP120) is a non-invasive blood flow detection device to be used in a medical/hospital setting for use by a medical professional. The device uses ultrasound and the Doppler effect to assess the flow of blood. The device consists of a signal processing unit and an adhesive strap. The device transmits ultrasonic waves from the ultrasonic transducer to a peripheral vessel such as the carotid artery. The Doppler shifted ultrasonic waves are reflected by moving blood cells back to the ultrasonic flow transducer. The reflected signal is received by the signal processing unit which outputs the Doppler signal wirelessly to a mobile medical application. The mobile medical application then processes the Doppler signal and displays a Max Velocity trace, Max VTI (Velocity Time Integral) and the Corrected Flow Time.
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    K Number
    K213974
    Device Name
    GEM FLOW COUPLER Monitor (GEM1020M-2)
    Manufacturer
    Synovis Micro Companies Alliance, Inc.
    Date Cleared
    2022-04-20

    (121 days)

    Product Code
    DPW, MVR
    Regulation Number
    870.2100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FLOW COUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FLOW COUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FLOW COUPLER Device is used in conjunction with the FLOW COUPLER Monitor, the FLOW COUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FLOW COUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively.
    Device Description
    The GEM FLOW COUPLER System is designed for the detection of blood flow in vessels. The GEM FLOW COUPLER System consists of components as described below: 1. FLOW COUPLER Device (Product Code MVR) - single-use implantable rings used to secure anastomosis of small vessels. This includes a 20MHz ultrasonic Doppler transducer (probe) which attaches to one of the FLOW COUPLER rings, and an external lead. 2. FLOW COUPLER Monitor (Product Code DPW) - portable monitor that provides the audible output of the FLOW COUPLER Device's pulsed Doppler ultrasound signal. A varying audible signal is produced when the FLOW COUPLER Device (probe) detects flow.
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    K Number
    K211589
    Device Name
    VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
    Manufacturer
    Remington Medical, Inc.
    Date Cleared
    2022-01-27

    (248 days)

    Product Code
    DPW
    Regulation Number
    870.2100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Remington Medical, Inc. VascuChek™ device is intended for the intraoperative and transcutaneous evaluation of blood flow in the following clinical applications: - · Intraoperative (Microvascular and Vascular) - · Intraoperative Neurological - · Transrectal and Peripheral Vascular
    Device Description
    VascuChek™ is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field. The VascuChek™ device follows Track 1. A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.
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    K Number
    K212065
    Device Name
    VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger
    Manufacturer
    Remington Medical, Inc.
    Date Cleared
    2021-10-07

    (97 days)

    Product Code
    DPW
    Regulation Number
    870.2100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Remington Medical, Inc. VascuChek™ Clinical Device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.
    Device Description
    VascuChek™ is a cardiovascular blood flowmeter comprised of two components: a nonsterile, single-use VascuChek™ Clinical Probe which connects to the reusable, nonsterile VascuChek™ Transceiver. The VascuChek™ device follows Track 1. A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receives to a receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.
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    K Number
    K201114
    Device Name
    Bidop 7
    Manufacturer
    Koven Technology, Inc.
    Date Cleared
    2021-01-05

    (253 days)

    Product Code
    DPW
    Regulation Number
    870.2100
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bidop 7 is intended for the detection of arterial and venous blood flow in the extremities as well as fetal heart sounds. The Bidop 7 displays bi-directional velocity waverical data and fetal heart rate with heartbeat indicator. The Bidop 7 probe selection is 2, 5, 8, and 10 MHz.
    Device Description
    The Bidop 7 is designed to provide both qualitative and quantitative information. The qualitative information mainly includes color visual display of waveform's shapes, including qualitative analysis of Photoplethysmography (PPG) and Doppler waveforms. The quantitative information is focused primarily on aiding the examiners in obtaining systolic segmental blood pressures, including the ABI (ankle-brachial index) and TBI (toe-brachial index). Additional quantitative measurements relate to the Doppler blood flow velocity waveforms.
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