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Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (3)
Not in Commercial Distribution
- 00850023296344 ()
Shoe insole size 3 (women 13.0 to 15.0) (men 11.0 to 12.50)
- Pressure monitoring insole
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (2-3)
Not in Commercial Distribution
- 00850023296337 ()
Shoe insole size (2-3) (women 11.0 to 12.5) (men 9.0 to 10.5)
- Pressure monitoring insole
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (2)
Not in Commercial Distribution
- 00850023296320 ()
Shoe insole size 2 (women 11.0 to 12.5) (men 9.0 to 10.5)
- Pressure monitoring insole
footbed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (12)
Not in Commercial Distribution
- 00850023296313 ()
Shoe insole size (12) (women 9.0 to 10.5) (men 7.0 to 8.5)
- Pressure monitoring insole
footbed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (1)
Not in Commercial Distribution
- 00850023296306 ()
Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to 8.5)
- Pressure monitoring insole
footbed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (01)
Not in Commercial Distribution
- 00850023296290 ()
Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to 8.5)
- Pressure monitoring insole
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (00)
Not in Commercial Distribution
- 00850023296283 ()
Shoe insole size 00 (women 3.0 to 6.5)
- Pressure monitoring insole
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (0)
Not in Commercial Distribution
- 00850023296276 ()
Shoe insole size 0 (women 7.0 to 8.5) (men 5.0 to 6.5)
- Pressure monitoring insole
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (3)
In Commercial Distribution
- 00850023296160 ()
Shoe insole size 3 (women 13.0 to 15.0) (men 11.0 to 12.50)
- Pressure monitoring insole
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (4)
In Commercial Distribution
- 00850023296085 ()
Shoe insole size 4 (men 13.0 to 15.0)
- Pressure monitoring insole
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (2)
In Commercial Distribution
- 00850023296061 ()
Shoe insole size 2 (women 11.0 to 12.5) (men 9.0 to 10.5)
- Pressure monitoring insole
footbed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (1)
In Commercial Distribution
- 00850023296054 ()
Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to 8.5)
- Pressure monitoring insole
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (0)
In Commercial Distribution
- 00850023296047 ()
Shoe insole size 0 (women 7.0 to 8.5) (men 5.0 to 6.5)
- Pressure monitoring insole
Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.
MEDHAB, LLC
7 Size (00)
In Commercial Distribution
- 00850023296030 ()
Shoe insole size 00 (women 3.0 to 6.5)
- Pressure monitoring insole
Adaptive classroom desk
RIFTON EQUIPMENT
R240
In Commercial Distribution
- 00850001752473 ()
- Ergonomic workdesk, manual
Adaptive classroom desk
RIFTON EQUIPMENT
R250
In Commercial Distribution
- 00850001752428 ()
- Ergonomic workdesk, manual
iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400063
In Commercial Distribution
- J00714000630631 ()
1400063
- Dental treatment application software
Orpyx Custom Sensory Insole refill is includes the a replacement set of insoles for the Orpyx Custom Sensory Insole system. This package contains only the insoles and product documentation such as an Instruction for Use manual.
The Orpyx Custom Sensory Insole system consists of a powered limb overload warning technology to provide real time notifications for pressure offloading. For wellness purposes the system also includes temperature sensors to monitor physiological parameters such as plantar foot skin temperature and motion sensors to measure activity. The Orpyx Custom Sensory Insole is fabricated from a foot impression.
The Orpyx Custom Sensory Insole system is intended to act as an adjunct to standard footcare, not a replacement. It is designed for use throughout everyday activities.
Orpyx Sensory Insoles system is indicated for people at risk of developing ulcers on the plantar aspect of the foot. The device is a prescription device and is not transferable to another person. The product does not diagnose or treat any conditions, it is meant to be used as an adjunct to current foot care practices.
Orpyx
SI000010
In Commercial Distribution
- 10185571000516 ()
- Pressure monitoring insole
The Orpyx Custom Sensory Insole system consists of a powered limb overload warning technology to provide real time notifications for pressure offloading. For wellness purposes the system also includes temperature sensors to monitor physiological parameters such as plantar foot skin temperature and motion sensors to measure activity. The Orpyx Custom Sensory Insole is fabricated from a foot impression. Orpyx Sensory Insoles system is indicated for people at risk of developing ulcers on the plantar aspect of the foot. The device is a prescription device and is not transferable to another person. The product does not diagnose or treat any conditions, it is meant to be used as an adjunct to current foot care practices.
Orpyx
SI000010
In Commercial Distribution
- 10185571000509 ()
- Pressure monitoring insole
The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support. The renewal insoles work as part of the Orpyx Sensory Insole system.
The following is included: 1 pair of custom insoles - Instructions for use manual - 4 months of RPM support - 3rd party contracted scanning, fitting and dispensing support
Orpyx
ORPYXSIV1
In Commercial Distribution
- 10185571000493 ()
10185571000493
- Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud to enable remote monitoring.
The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 4 months of RPM support - support for scanning, fitting and dispensing.
Orpyx
ORPYXSIV1
In Commercial Distribution
- 10185571000486 ()
10185571000486
- Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud to enable remote monitoring.
The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 6 months of RPM support - support for scanning, fitting and dispensing.
Orpyx
ORPYXSIV1
In Commercial Distribution
- 10185571000479 ()
10185571000479
- Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud to enable remote monitoring.
The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 12 months of RPM support - support for scanning, fitting and dispensing.
Orpyx
ORPYXSIV1
In Commercial Distribution
- 10185571000462 ()
10185571000462
- Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud to enable remote monitoring.
The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 4 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution
- 10185571000417 ()
10185571000417
- Pressure monitoring insole
Orpyx Flex Sensory Insoles refill (1 pair) - This is a set of pre-fabricated sensory insoles compatible with the Orpyx Sensory Insole system.
Included in the package: pre-fabricated sensory insoles - instructions for use manual
Orpyx
ORPYXSIV1
In Commercial Distribution
- 10185571000400 ()
10185571000400
- Pressure monitoring insole
Orpyx Custom Sensory Insoles refill (1 pair) - This is a set of custom sensory insoles compatible with the Orpyx Sensory Insole system.
Included in the package: Pair of custom sensory insoles - instructions for use manual.
Orpyx
ORPYXSIV1
In Commercial Distribution
- 10185571000363 ()
10185571000363
- Pressure monitoring insole
The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support. The renewal insoles work as part of the Orpyx Sensory Insole system.
The following is included: 1 pair of custom insoles - Instructions for use manual - 4 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution
- 10185571000356 ()
10185571000356
- Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud for remote monitoring purposes.
The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 6 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution
- 10185571000349 ()
10185571000349
- Pressure monitoring insole
The Orpyx® Custom Sensory Insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into custom fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud for remote monitoring purposes.
The following is included: 1 pair of custom insoles - Digital Display - Charging accessories - Instructions for use manual - 12 months of RPM support
Orpyx
ORPYXSIV1
In Commercial Distribution
- 10185571000332 ()
10185571000332
- Pressure monitoring insole
The Orpyx® Flex Sensory insole system is designed to help patients at risk of foot ulceration. The system consists of pressure sensors integrated into pre-fabricated shoe insoles which wirelessly communicates with a display application running on a smartphone or digital display. In addition to pressure, the device monitors plantar foot temperature and movement. Sensor data is collected by the device and sent to the cloud to enable remote monitoring.
The following is included in the Orpyx Flex Sensory Insoles Start Up Kit: - 1 pair of flex insoles - Digital Display - Charging accessories - Instructions for use manual
Orpyx
ORPYXSIV1
In Commercial Distribution
- 10185571000172 ()
10185571000172
- Pressure monitoring insole
The Stratus EEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video synchronized to the EEG. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal.
The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Acquisition
- Bioelectrical signal analysis software
Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal.
The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Client Software
- Bioelectrical signal analysis software
Stratus EEG is software system used to manage and review EEG examinations. It works on data acquired by third party EEG equipment that is imported into the system. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal.
The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Server Software
- Bioelectrical signal analysis software
Stratus EEG Web is software system used to manage and review EEG examinations. It works on data
acquired by third party EEG equipment that is imported into the system. The EEG is presented in a
conventional way and conventional signal processing is applied such as re-montaging and band pass
filtering. The system is also capable of presenting digital video synchronized to the EEG if this is
available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal.
The software is designed using service oriented architecture enabling the possibility of reviewing data
over the Web without the use of additional remote desktop software solutions. The two main components
of Stratus Web are Web Centrum and Web Review.
Kvikna Medical ehf.
Web
In Commercial Distribution
- 05694110068040 ()
- Bioelectrical signal analysis software
Lifelines iEEG is software system used to manage and review EEG examinations. It works on data
acquired by third party EEG equipment that is imported into the system. The EEG is presented in a
conventional way and conventional signal processing is applied such as re-montaging and band pass
filtering. The system is also capable of presenting digital video synchronized to the EEG if this is
available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal.
The software is designed using service oriented architecture enabling the possibility of reviewing data
over WAN without the use of additional remote desktop software solutions. The two main components
of Lifelines iEEG are iEEG Centrum and iEEC Review.
Kvikna Medical ehf.
KSW2060
Not in Commercial Distribution
- 05694110063069 ()
- Bioelectrical signal analysis software
Lifelines iEEG is software system used to manage and review EEG examinations. It works on data
acquired by third party EEG equipment that is imported into the system. The EEG is presented in a
conventional way and conventional signal processing is applied such as re-montaging and band pass
filtering. The system is also capable of presenting digital video synchronized to the EEG if this is
available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal.
The software is designed using service oriented architecture enabling the possibility of reviewing data
over WAN without the use of additional remote desktop software solutions. The two main components
of Lifelines iEEG are iEEG Centrum and iEEC Review.
Kvikna Medical ehf.
KSW2050
Not in Commercial Distribution
- 05694110063052 ()
- Bioelectrical signal analysis software
NeuroMatch is a Software as Medical Device intended for physicians to review EEG data.
LVIS CORPORATION
1.0.4
In Commercial Distribution
- 00850056774000 ()
- Bioelectrical signal analysis software
Persyst ESI powered by Epilog provides Electrical Source Imaging as a service to a clinical user. The clinical user does not interact directly with the device. In the Persyst ESI powered by Epilog service, the device is used by Epilog operators to generate a report.
Persyst ESI powered by Epilog is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least 3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images of an individualized head model and an individualized MRI image.
Clouds of Care
v2
- Bioelectrical signal analysis software
PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technologist / Operator in combination with Persyst EEG Review and Analysis Software on both adult and pediatric subjects at least 3 years of age for 3D visualization of the human brain function recorded with EEG and using a patient-specific MR image.
Clouds of Care
v2
- Bioelectrical signal analysis software
PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least
3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images
of an individualized head model and an individualized MRI image.
Clouds of Care
1.0.0
Not in Commercial Distribution
- 05430000733007 ()
- Bioelectrical signal analysis software