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The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. Ovation should never be used to lift subjects off the ground and should never be connected to inanimate objects. Ovation should only be operated by clinicians and trained healthcare professionals who have read and understand the instructions for use and have passed the Ovation training competency exam conducted by an Aretech trainer or a certified staff trainer.
The Ovation 400 model allows for a patient weight capacity of up to 400 pounds with a dynamic body-weight support range of 10 to 200 pounds.
ARETECH, LLC
OV-400
In Commercial Distribution
- 00850018836029 ()
- Gait rehabilitation frame, electric
The ZeroG Gait & Balance System is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG can also be used to train subjects ambulating on a treadmill. ZeroG should never be used to lift and transport subjects, and should never be connected to inanimate objects. ZeroG should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZGGB-V3
In Commercial Distribution
- 00850018836012 ()
- Gait rehabilitation frame, electric
Intera 3000 Hepatic Artery Infusion Pump and Operating Room Prep Kit
Intera Oncology Inc.
AP-03000H
In Commercial Distribution
- 00850014110147 ()
- Total Volume: 30 Milliliter
AP03000H
- Implantable intrathecal infusion pump, nonprogrammable
The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-02
In Commercial Distribution
- 00850005539025 ()
- Neuro-controlled joint movement exoskeleton
The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-01
In Commercial Distribution
- 00850005539018 ()
- Neuro-controlled joint movement exoskeleton
Gait Trainer
RIFTON EQUIPMENT
K640
In Commercial Distribution
- 00858101008278 ()
- Gait rehabilitation frame, manual
Gait Trainer
RIFTON EQUIPMENT
K650
In Commercial Distribution
- 00858101008285 ()
- Gait rehabilitation frame, manual
Gait Trainer
RIFTON EQUIPMENT
K630
In Commercial Distribution
- 00858101008261 ()
- Gait rehabilitation frame, manual
Powered gait trainer and transfer device
RIFTON EQUIPMENT
K660
In Commercial Distribution
- 00858101008292 ()
- Gait rehabilitation electronic walker
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution
- 05711665003033 ()
- Weight: 2144 Kilogram
- Height: 225 Centimeter
- Depth: 197 Centimeter
- Width: 291 Centimeter
9SYS2070
- Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
BodyMD Gamma Camera System
Not in Commercial Distribution
- 05711665003026 ()
- Width: 291 Centimeter
- Depth: 197 Centimeter
- Height: 225 Centimeter
- Weight: 2144 Kilogram
9PMS3131
- Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution
- 05711665003019 ()
- Width: 291 Centimeter
- Depth: 197 Centimeter
- Height: 225 Centimeter
- Weight: 2144 Kilogram
9PMS3131
- Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
QuantumCam Gamma Camera System
In Commercial Distribution
- 05711665003002 ()
- Weight: 2144 Kilogram
- Height: 225 Centimeter
- Depth: 197 Centimeter
- Width: 291 Centimeter
9SYS2070
- Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
CardioMD Gamma Camera System
Not in Commercial Distribution
- 05711665002029 ()
- Width: 284 Centimeter
- Depth: 150 Centimeter
- Height: 150 Centimeter
- Weight: 815 Kilogram
9PMS3060
- Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
CorCam Gamma Camera System
In Commercial Distribution
- 05711665002012 ()
- Width: 284 Centimeter
- Depth: 150 Centimeter
- Height: 150 Centimeter
- Weight: 815 Kilogram
9PMS3060
- Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
CorCam Gamma Camera System
In Commercial Distribution
- 05711665002005 ()
- Weight: 815 Kilogram
- Height: 150 Centimeter
- Depth: 150 Centimeter
- Width: 284 Centimeter
9COR2370
- Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
c.cam Gamma Camera System
In Commercial Distribution
- 05711665001008 ()
- Weight: 1350 Kilogram
- Height: 169 Centimeter
- Depth: 229 Centimeter
- Width: 244 Centimeter
9VIR1200
- Stationary gamma camera system
Magnetic shield for the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution
- 00862563003191 ()
403350
- Intraurethral valve/pump
Magnetic remote control for the inFlow Device
- with base station and medical charger
VESIFLO INC
August 2021
In Commercial Distribution
- 00862563003184 ()
403507K
- Intraurethral valve/pump
Recharger for inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution
- 00862563003177 ()
403320
- Intraurethral valve/pump