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510(k) Data Aggregation

    K Number
    K202979
    Device Name
    MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
    Manufacturer
    Lode B.V.
    Date Cleared
    2020-12-21

    (82 days)

    Product Code
    ISD
    Regulation Number
    890.5360
    Why did this record match?
    Product Code :

    ISD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended to be used as a stress test device in a medical environment. The main goal of the devices is to create reproducible stress tests. With cycling ergometers typically workload (watt) is imposed. This product is designed both for manual operation and for control by external software. This device will be used in conjunction with another medical device to obtain other important physiological data, allowing a physician to evaluate a test subjects physical status.
    Device Description
    MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra
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    K Number
    K183296
    Device Name
    REAL Immersive System
    Manufacturer
    Penumbra, Inc.
    Date Cleared
    2019-03-18

    (111 days)

    Product Code
    ISD
    Regulation Number
    890.5360
    Why did this record match?
    Product Code :

    ISD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The REAL Immersive System is an immersive virtual reality and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of virtual environments and full presence tracked avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a seated position in a clinical environment and prescribed and supervised by a medical professional trained in rehabilitation therapy.
    Device Description
    REAL Immersive System is a digital hardware and software medical device platform using a combination of virtual environments and full presence tracked avatars for visual feedback. It is designed for use in healthcare and focusing on physical and neuro rehabilitation. The use of the device is intended to be in a clinical environment supervised by a medical professional trained in rehabilitation therapy. REAL Immersive System contains the following components: - . All-in-One HMD with Software Application - . HMD Controller - Wireless Transmitter Module (WTM or Large Sensor) . - Wireless Sensor Module (WSM or Small Sensor) . - . Tablet with Software Application - . Sensor Charger (charging station) - Router ● - Router Battery ● - Sensor Bands .
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    K Number
    K143512
    Device Name
    ActiSpec Activity Monitor
    Manufacturer
    SLEEP MODUS, INC.
    Date Cleared
    2015-08-26

    (258 days)

    Product Code
    ISD
    Regulation Number
    890.5360
    Why did this record match?
    Product Code :

    ISD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ActiSpec® is a small limb worn activity monitor designed for documents associated with applications in physiological monitoring. The device intended use is to analyze limb activity associated with movement during sleep. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.
    Device Description
    ActiSpec® consists of a pair of toe bands containing firmware within the toe band housing, and an offline data download, scoring, and report generation tool. The ActiSpec® toe band is a small, battery-operated activity monitor worn on the big (great) toe. ActiSpec® typically is packaged as a pair of toe bands, one for each big toe. ActiSpec® measures, records, and scores movements caused by the contraction of the tibialis anterior muscle responsible for movement of the big toe and dorsiflexion of the ankle and foot. These movements are detected by the accelerometer. The intention is for the patient to wear the toe bands only while sleeping for five (5) consecutive nights. After the fifth night, the patient returns the toe bands to Sleep Modus and a report is generated for the care provider. The generated report contains statistical information regarding the movements of the patient each night including a graph showing those movements. The report is in the form of a PDF document emailed to the care provider. ActiSpec® has a 2-year shelf life in addition to a 120-hour active data collection period. Device activation occurs upon removal of the toe bands from the light-proof packaging.
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    K Number
    K112121
    Device Name
    ERGOSELECT/GE
    Manufacturer
    ERGOLINE GMBH
    Date Cleared
    2012-10-31

    (464 days)

    Product Code
    ISD
    Regulation Number
    890.5360
    Why did this record match?
    Product Code :

    ISD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.
    Device Description
    The Ergoselect is the result of long-standing experience and its consequent implementation. The system is convincing thru the optimal, and therefore, cost-effective configuration of the ergometer according to in medical ergometer specific requirements. Modern computer control allows Stand-alone operation of the ergometer as well as comfortable control via external devices (PC system). Ergoline Ergoselect / GE measures data concerning patients procedures and in conjunction with ergometer bicycles procedures. Ergoselect / GE ergometer includes following models (P/K versions): Ergoselect 50, Ergoselect 100 / 200, Ergoselect 600, Ergoselect 1000, Ergoselect 1200, Optibike 50 med, Optibike med.
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    K Number
    K080545
    Device Name
    ACTITRAINER
    Manufacturer
    ACTIGRAPH, LLC
    Date Cleared
    2008-07-24

    (148 days)

    Product Code
    ISD
    Regulation Number
    890.5360
    Why did this record match?
    Product Code :

    ISD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ActiTrainer is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The ActiTrainer can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
    Device Description
    The ActiTrainer is housed in a polycarbonate plastic housing. It is 8.5 cm long by 3.4 cm wide by 1.6 cm thick and it weights 51 grams. It also has an optional Polar heart strap. Data is downloaded into a PC via a USB plug and the data is displayed with ActiGraph LLC's ActiLife software.
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    K Number
    K053078
    Device Name
    ERGOSELECT 100 K/P, ERGOSELECT 200 K/P
    Manufacturer
    ERGOLINE GMBH
    Date Cleared
    2006-04-27

    (176 days)

    Product Code
    ISD
    Regulation Number
    890.5360
    Why did this record match?
    Product Code :

    ISD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.
    Device Description
    The Ergoselect 100 K/P; Ergoselect 200 K/P ergometer has been designed to meet the medical and ergonomic requirements for an efficient and relevant stress test of the cardiovascular system. Modern computer control allows Stand-alone operation of the ergometer as well as comfortable control via external devices (PC system). Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures. The ergometry system Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P consists out of the following components: Basic unit: Ergoselect 100: Ergoselect 200 Control panel type P / K Control unit: Ergoline Ergoselect 100 K/P; Ergoselect 200 K/P ergometer measures data concerning patients procedures and in conjunction with ergometer bicycles procedures.
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    K Number
    K990866
    Device Name
    QUINTON MEDTRACK CR PLUS TREADMILL
    Manufacturer
    QUINTON, INC.
    Date Cleared
    1999-04-29

    (44 days)

    Product Code
    ISD
    Regulation Number
    890.5360
    Why did this record match?
    Product Code :

    ISD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quinton MedTrack CR Plus Treadmill is intended to be used as a rehabilitation device for cardiovascular conditioning. The intended population are ambulatory patients undergoing exercise rehabilitation.
    Device Description
    Not Found
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    K Number
    K990813
    Device Name
    REHCOR
    Manufacturer
    ELECTROMED CORP.
    Date Cleared
    1999-04-12

    (32 days)

    Product Code
    ISD, MEA
    Regulation Number
    890.5360
    Why did this record match?
    Product Code :

    ISD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Useful for physiotherapy in redevelopment of muscles or for restoration of motion to joints or for use as an adjunct treatment for obesity. The bicycle would be Class I exempt when sold without measuring capability but is available with ECG and/or blood pressure measuring options thus making it Class II, not exempt. The unit's workload can be controlled by an RS-232 input for connection to ECG stress test systems (supplied by other manufacturers)
    Device Description
    Not Found
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    K Number
    K962855
    Device Name
    ULE-2, MULE-2, HAND ACCESSORY KIT
    Manufacturer
    PENNY AND GILES BIOMETRICS LTD.
    Date Cleared
    1996-12-11

    (142 days)

    Product Code
    ISD
    Regulation Number
    890.5360
    Why did this record match?
    Product Code :

    ISD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    Not Found
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    K Number
    K952163
    Device Name
    DAVID BACK CLINIC SYSTEM
    Manufacturer
    KINETIC RESOURCES, INC.
    Date Cleared
    1996-08-12

    (462 days)

    Product Code
    ISD
    Regulation Number
    890.5360
    Why did this record match?
    Product Code :

    ISD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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