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Software, Version 1.0, Precision Treatment Planning System
The Accuray Precision Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.
ACCURAY INCORPORATED
1050242
In Commercial Distribution
- M65810502420 ()
NA
- Linear accelerator system
- Radiation therapy treatment planning computer
Active Monitoring Portal
Lifesignals, Inc.
UA2550-C
In Commercial Distribution
- B353UA2550C1 ()
- Wireless patient monitor/sensor reporting software, professional-only
- Wearable multiple vital physiological parameter monitor
GCX Mounting rails for front supports in PM/KM/XM carriers only (set, includes hardware) H8-010-51 GCX track sold separately
SKYTRON LLC
H8-200-01-GCX
In Commercial Distribution
- 10841736114091 ()
- General utility supply system, ceiling-mounted
Pathway® NMR 200 Dual Channel Module
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
NMR 200
In Commercial Distribution
- 00852423006394 ()
NMR 200
- Perineometer
- Psychophysiological biofeedback system
Pathway® MR-10 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-10
In Commercial Distribution
- 00852423006073 ()
9700
- Perineometer
- Psychophysiological biofeedback system
Pathway® MR-15 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-15
In Commercial Distribution
- 00852423006066 ()
9715
- Perineometer
- Psychophysiological biofeedback system
Pathway® MR-20 Dual Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-20
In Commercial Distribution
- 00852423006059 ()
9710
- Perineometer
- Psychophysiological biofeedback system
Pathway® MR-25 Dual Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-25
In Commercial Distribution
- 00852423006042 ()
9725
- Perineometer
- Psychophysiological biofeedback system
Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1010
In Commercial Distribution
- 07640136270019 ()
- External orthopaedic fixation system, single-use
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.
The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.
VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected.
The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.
The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050G Adapter
In Commercial Distribution
- B595L2050G0 ()
L2050G
- Cardiac arrhythmia monitoring system
- Wearable multiple vital physiological parameter monitoring system
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.
The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.
VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected.
The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.
The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
CS2050 Chest Sensor
In Commercial Distribution
- B595CS20500 ()
- B595L2050G1 ()
CS2050
- Cardiac arrhythmia monitoring system
- Wearable multiple vital physiological parameter monitoring system
E-Scribe ECG Data Management Workstation - Enterprise system, floating; English system language; 110V power; Tower workstation computer hardware (no keyboard, mouse, or display);
WELCH ALLYN, INC.
901134
In Commercial Distribution
- 00732094265057 ()
ESWKST-DAA-AXXXX
- Patient health record information system application software
Control Unit Includes: Control Unit;Hardware Key;Carrying Case Keys 2 ; Adapters 3; Battery Charger; USB Cable;Information Manuals and Carrying Case
Medos International Sàrl
91-4205US
Not in Commercial Distribution
- 10886704064947 ()
- 10886704071426 ()
914205US
- Infusion pump programmer
Transport Chair Replacement Rear Wheel Fits Wc1001 W/Hardware Fits Wc1001 8 Inch Black Not Nat Rubber Ltx Non Sterile Reusable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GEY1TWA
In Commercial Distribution
- 20885632063234 ()
- 10885632063237 ()
- Wheelchair wheel
Device with hardware comprising a force plate and software for analysis of center of pressure during static and dynamic tests of stance.
EQUIDOR MEDTECH LLP
EQPOS
In Commercial Distribution
- 08908024776005 ()
- Posturography system
Individual 6" Curved Calf Pads (Set) for use with various Motion Concepts independent legrests. Fabric covered foam pad. One-size. Mounting hardware included.
Motion Concepts Inc
D-0101-0157-CCP
In Commercial Distribution
- 07540147002510 ()
CCP
- Wheelchair legrest pad
The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb.
The MyoPro 2x Assembly Kit consists of a combination of the following components, some or all of which are not yet assembled: a shoulder harness, a custom-made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set wrist module, a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station.
The MyoPro 2x EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 2x filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro 2x to assist the User to initiate
and complete desired motions.
Myomo, Inc.
Motion G Right - 30382 rev1
In Commercial Distribution
- 00855846007252 ()
30382
- Psychophysiological biofeedback system
- Elbow orthosis
- Hand orthosis
The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb.
The MyoPro 2x Assembly Kit consists of a combination of the following components, some or all of which are not yet assembled: a shoulder harness, a custom-made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set wrist module, a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station.
The MyoPro 2x EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 2x filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro 2x to assist the User to initiate
and complete desired motions.
Myomo, Inc.
Motion G Left - 30381 rev1
In Commercial Distribution
- 00855846007245 ()
30381
- Psychophysiological biofeedback system
- Elbow orthosis
- Hand orthosis
The Mobile Arm Rehabilitation Kit version 2 (MARK2) is a kit containing two (left and right) MyoPro upper extremity limb orthoses. A MyoPro upper extremity limb orthosis is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb.
The MARK2 product consists of a combination of the following components: shoulder harnesses, adjustable limb orthoses (braces), powered elbow orthoses with surface electromyography (EMG) sensors, static or manually set multi-articulating wrists (MAW), static hand orthoses or powered hand orthoses with EMG sensors, an interchangeable battery with a separate recharging station, an MTS chafe with loop for anti-rotation strap, a laptop, and a product carrying case/bag.
The MyoPro’s EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. A MyoPro device filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro to assist the User to initiate and complete desired motions.
Myomo, Inc.
MARK2 29860
In Commercial Distribution
- 00855846007238 ()
MARK2 29860
- Psychophysiological biofeedback system
- Elbow orthosis
- Hand orthosis
The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb.
The MyoPro 2x consists of a combination of the following components: a shoulder harness, a custom-made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set wrist module, a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station.
The MyoPro 2x EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 2x filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro 2x to assist the User to initiate
and complete desired motions.
Myomo, Inc.
Motion G Right - 29858 rev1
In Commercial Distribution
- 00855846007221 ()
29858
- Psychophysiological biofeedback system
- Elbow orthosis
- Hand orthosis