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BOISE ANEURYSM-LF
MEDLINE INDUSTRIES, INC.
DYNJ41523G
In Commercial Distribution
- 40198459279042 ()
- 10198459279041 ()
DYNJ41523G
- General surgical procedure kit, non-medicated, single-use
Personal Use Kit OC-Auto, for Boise, ID
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-VA1 915908
In Commercial Distribution
- 00816917022451 ()
- Faecal occult blood IVD, reagent
The Hand of Hope (HOH) is a therapy device (exoskeleton) used for neuromuscular rehabilitation
of the hand and forearm. HOH functions as a biofeedback device where surface electromyography
(sEMG) electrodes depict voluntary muscle activation. The depicted signals are processed and
simplified, and can be seen by a convenient presentation of visual feedback. The sEMG readout
enables patients to monitor the fundamental neuromuscular functional state. Therefore, impairment,
functional limitation and impaired volitional movement due to stroke or other neurologic or
orthopaedic diseases can be easily presented and utilized by a sensory signal. Patient’s attention is
drawn to the task through a visually displayed sEMG signal and consequently used for the initiation
of the motor task. This biofeedback mechanism promotes motor learning via interactive use. In
particular, stroke is one of the leading causes of adult disability, and hand rehabilitation after stroke
is a very challenging part thereof. However, it is well known that sensory signals such as visual
sensory inputs reach the motor cortex and modulate motor cortex function and excitability, and
therefore can improve motor learning. Since active participation and initiation of the movement is the
key to success, using the biofeedback system, HOH motivates patients to actively interact with the
system during an sEMG controlled task-related training regime
Rehab-Robotics Company Limited
HOH4-SM-LR-W
In Commercial Distribution
- 04897113220014 ()
- Virtual-display rehabilitation system, powered-support, upper-limb
The Ampa One System is a computerized, electromechanical medical device that produces and delivers
non-invasive, magnetic fields to induce electrical currents in brain tissues to target specific regions of the
cerebral cortex. The system contains two different coils for targeting different regions of the brain. The L
Coil is designed to target the left dorsolateral prefrontal cortex (DLPFC). The M Coil is designed to target
the bilateral prefrontal cortex (DMPFC). Both coils are used within the Ampa One System to treat Major
Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from
prior antidepressant medication in the current episode.
Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neural
tissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current are
generated with a circuit containing a capacitor connected to the stimulating coil. With the capacitor
charged to a certain level, the conducting state will cause the discharging of the capacitor through the coil.
A magnetic field is generated proportional to this current. The rapid change in the magnetic field induces
a current in conducting materials e.g. the body tissue. If the current induced in the human body is of
sufficient amplitude and duration, it will excite neurons.
Neuromodulatory Devices & Applications LLC
AMPA-001
In Commercial Distribution
- 00860011991205 ()
- Magnetic neural stimulation system
The AnovoTM Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit).
Anovo Surgeon Console (UDI # 07290018151013) packed with its power cable (UDI # 07290018151037)
The Anovo Surgeon Console comprised of Arm Controllers (Joysticks and Thumbsticks), an Adjustable Controllers Stand, a PC with Touch Screen, Manual Release Tool and the Power Adapter, and allowing the operating surgeon to operate the Anovo Instrument Arms. There are two sets of Arm Controllers for the Anovo System: two Thumbsticks and two ARMS Controllers. The ARMS Controllers are enabled only when the system is at “resume” state and allow for the accurate control of the Anovo Instrument ARMS during the surgical procedure. Like the Anovo Instrument Arm, each ARMS Controllers has three joints: wrist, elbow and shoulder, so that each Anovo Instrument ARM moves accordingly to Controller's movement. The surgeon-held Controller handle is above the elbow joint and allows for multiple functionality transitions.
MOMENTIS SURGICAL LTD
-
In Commercial Distribution
- 17290018151027 ()
- Endoscopic electromechanical surgical system
- Electrical mains power cable
Nerivio Infinity is a wireless remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. This prescription device is self-applied to the upper arm and should be used in the home environment at the onset of migraine headache or aura. or every other day for preventive treatment. Nerivio Infinity utilizes an endogenous descending analgesic mechanism in which pain in one part of the body inhibits pain in multiple remote body regions (Conditioned Pain Modulation [CPM]).
Nerivio Infinity is a wireless wearable battery-operated device controlled by a mobile software application. The battery is rechargeable, and the electronic unit can be used up to 3 years. The Nerivio Infinity Refill is a disposable and replaceable unit. The refill unit is sufficient for up to 18 treatments of 45 minutes each.
The application has a graphical user interface (GUI) that includes graphical controls that the user can select using a touch screen. This application activates the stimulation, controls the stimulation intensity, monitors the treatment duration, and pauses and terminates the stimulation. The application also provides notifications and indications on the connection state and the remaining number of treatments.
The Nerivio Infinity package under this UDI contains 1 refill unit.
Theranica Bio-Electronics Ltd.
FGD000100
In Commercial Distribution
- 07290017578118 ()
FGD000100
- Craniofacial analgesia electrical stimulator
Nerivio Infinity is a wireless remote electrical neuromodulation (REN) device for the acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. This prescription device is self-applied to the upper arm and should be used in the home environment at the onset of migraine headache or aura. or every other day for preventive treatment. Nerivio Infinity utilizes an endogenous descending analgesic mechanism in which pain in one part of the body inhibits pain in multiple remote body regions (Conditioned Pain Modulation [CPM]).
Nerivio Infinity is a wireless wearable battery-operated device controlled by a mobile software application. The battery is rechargeable, and the electronic unit can be used up to 3 years. The Nerivio Infinity Refill is a disposable and replaceable unit. The refill unit is sufficient for up to 18 treatments of 45 minutes each.
The application has a graphical user interface (GUI) that includes graphical controls that the user can select using a touch screen. This application activates the stimulation, controls the stimulation intensity, monitors the treatment duration, and pauses and terminates the stimulation. The application also provides notifications and indications on the connection state and the remaining number of treatments.
The Nerivio Infinity package under this UDI contains 3 refill units.
Theranica Bio-Electronics Ltd.
FGD000100
In Commercial Distribution
- 07290017578101 ()
FGD000100
- Craniofacial analgesia electrical stimulator
The AnovoTM Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point.
The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit).
The Anovo Surgeon Console comprised of Arm Controllers (Joysticks and Thumbsticks), an Adjustable Controllers Stand, a PC with Touch Screen, Manual Release Tool and the Power Adapter, and allowing the operating surgeon to operate the Anovo Instrument Arms.
There are two sets of Arm Controllers for the Anovo System: two Thumbsticks and two ARMS Controllers. The ARMS Controllers are enabled only when the system is at “resume” state and allow for the accurate control of the Anovo Instrument ARMS during the surgical procedure. Like the Anovo Instrument Arm, each ARMS Controllers has three joints: wrist, elbow and shoulder, so that each Anovo Instrument ARM moves accordingly to Controller's movement. The surgeon-held Controller handle is above the elbow joint and allows for multiple functionality transitions.
MOMENTIS SURGICAL LTD
10
In Commercial Distribution
- 07290018151013 ()
- 17290018151010 ()
FP-03-0003
- Endoscopic electromechanical surgical system
The NeoCoil 3.OT 8-Channel Shoulder Array Coil is a multi-element phased array
receive only coil used for obtaining diagnostic images of the shoulder in Magnetic
Resonance Imaging Systems. Compared to predicate devices, the submitted
device offers easier patient setup and greater SNR due to its compatibility with
3.OT MRI scanners.
The submitted device consists of semi-flexible foam covered housing, consisting
of eight antennas. The antennas are uniquely positioned with the appropriate
overlap to cancel out mutual coupling effects from adjacent antennas or
decoupled from an adjacent antenna using a transformer. Pre-amplifier
decoupling reduces any remaining decoupling between the antennas.
The coil is held in place over the imaging area via a cross body strap. A system
interface cable connects to the coil at the top of the housing. The flexible foam
covered housing along with the body strap enable the proper positioning on the
patient before laying down and holds the coil in place while scanning is being
performed.
To ensure safety, each antenna is equipped with active and passive transmit
decoupling circuits. Active decoupling is achieved via diodes that receive signals
from the scanner to turn the coil to a high impedance state during system RF
transmit. Crossed diodes are installed on each antenna acting as passive
switches. These passive switches provide additional safety in case the active
circuitry does not receive signal from the scanner.
NEOCOIL, LLC
05
In Commercial Distribution
- 00856181003053 ()
- MRI system coil, radio-frequency
AIR SUPPLY
Air supply units may be compatible with PremierPro™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed.
MRI SAFETY
PremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors:
Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh.
Safety strap buckles are constructed from Polypropylene.
Air supply fasteners are manufactured from non-ferrous metal.
Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts.
Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI.
CLEANING
Disposable Models
The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.
SVS LLC
3703
In Commercial Distribution
- 10818566019193 ()
- 00818566019196 ()
- Length: 50 Inch
3703
- Patient transfer system, powered