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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting: Wrist, Forearm, Elbow, Shoulder, Hip, Knee, Ankle, Documentation of amputation, ankylosis, and arthrodesis for the above joints This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
N400
In Commercial Distribution

  • 05060481690065 ()


  • Electronic goniometer/kinesiology sensor
Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting. Hand (fingers and thumb) – active and passive, extension and flexion, abduction and adduction, lateral deviations and rotational deformities, calculation of total active motion and total passive motion Wrist – active and passive, extension and flexion, radial and ulnar deviation This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
N300
In Commercial Distribution

  • 05060481690058 ()


  • Electronic goniometer/kinesiology sensor
myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App Android
In Commercial Distribution

  • 09413000126273 ()


  • Electronic goniometer/kinesiology sensor
myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App iOS
In Commercial Distribution

  • 09413000126259 ()


  • Electronic goniometer/kinesiology sensor
Digital Knee sensor is attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
DK-017-R
In Commercial Distribution

  • 09413000123418 ()


  • Electronic goniometer/kinesiology sensor
Digital Knee sensor is attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
DK-017-L
In Commercial Distribution

  • 09413000123395 ()


  • Electronic goniometer/kinesiology sensor
Digital Knee sensor is attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
DK-013
In Commercial Distribution

  • 09413000113839 ()


  • Electronic goniometer/kinesiology sensor
The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 device The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.
GKC MANUFACTURING PTY LTD
2001-CHG-DOC-US
In Commercial Distribution

  • 09369998000562 ()
  • 09369998308569 ()


  • Neuromuscular motion disorder ambulatory recorder/analyser
The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.
GKC MANUFACTURING PTY LTD
GKC-2000
In Commercial Distribution

  • 09369998208654 ()
  • 09369998107773 ()


  • Neuromuscular motion disorder ambulatory recorder/analyser
The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms such as Parkinson's disease, including tremor, bradykinesia and dyskinesia
GKC MANUFACTURING PTY LTD
GKC-2009
In Commercial Distribution

  • 09369998040162 ()


  • Neuromuscular motion disorder ambulatory recorder/analyser
The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 device The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.
GKC MANUFACTURING PTY LTD
2022-CHG-DOC-UNI
In Commercial Distribution

  • 09359011000327 ()


  • Neuromuscular motion disorder ambulatory recorder/analyser
The PKG Smart Charger is a portable charging station to be used in conjunction with 2000-LOG-004 device The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.
GKC MANUFACTURING PTY LTD
2022-CHG-DOC-004
In Commercial Distribution

  • 09359011000310 ()


  • Neuromuscular motion disorder ambulatory recorder/analyser
The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.
GKC MANUFACTURING PTY LTD
2000-LOG-004
In Commercial Distribution

  • 09359011000303 ()


  • Neuromuscular motion disorder ambulatory recorder/analyser
The PKG Smart Charger is a portable charging station to be used in conjunction with GKC-2000 device The Personal Kinetigraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.
GKC MANUFACTURING PTY LTD
2022-CHG-DOC-V1.2
In Commercial Distribution

  • 09359011000297 ()


  • Neuromuscular motion disorder ambulatory recorder/analyser
The Personal KinetiGraph (PKG) is intended to quantify kinematics of movement disorder symptoms in conditions such as Parkinson's disease, including tremor, bradykinesia and dyskinesia.
GKC MANUFACTURING PTY LTD
2023-LOG-G3
In Commercial Distribution

  • 09359011000280 ()


  • Neuromuscular motion disorder ambulatory recorder/analyser
Knee System
Tracpatch Health, LLC
4000-0-1000
In Commercial Distribution

  • 00844588044311 ()
4000-0-1000

  • Electronic goniometer/kinesiology sensor
Temp Pal is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Temp Pal can be used at home and healthcare center.
iWEECARE Co., Ltd.
STP-MB01-1
In Commercial Distribution

  • 04712977931060 ()
  • 14712977931067 ()


  • Wireless patient thermometer, reusable
The WISE is a magnetic and inertial unit including 3D accelerometers, gyroscopes and magnetometers.
NCS LAB SRL
WISE01
In Commercial Distribution

  • 08051122041008 ()


  • Electronic goniometer/kinesiology sensor
The Bluetooth Wearable Thermometer is an electronic thermometer using a sensor to measure right armpit temperature. Its operation is based on measuring the natural thermal radiation emanating from the armpit and the adjacent surfaces. Its software performs a calculation that factors in room temperature, and then a calculated temperature is displayed on the mobile device. Purpose of measuring body temperature is to check body condition by measuring correct temperature in important part of body and both measured room temperature and relative humidity are to show environmental conditions. In case of right armpit measurement, this product searches the highest temperature from the right armpit.
HuBDIC Co., Ltd.
HMT-100
In Commercial Distribution

  • 08800132200413 ()


  • Wireless patient thermometer, reusable
Sens is an inertial sensor to measure the range of motion and to compare the symmetry between the injured limb’s amplitude and the healthy limb.
KINVENT HELLAS
Sens V2R01
In Commercial Distribution

  • 03770011995554 ()


  • Electronic goniometer/kinesiology sensor
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