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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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
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 Titronics range of motion device is a dual inclinometer system. A goniometer is powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint.
TITRONICS RESEARCH & DEVELOPMENT COMPANY
Ty-tROM G-2000
In Commercial Distribution

  • 00860447001721 ()


  • Electronic goniometer/kinesiology sensor
The Radink Sensor uses a combination of a 3-axis accelerometer, a 3-axis gyroscope, and a 3-axis magnetometer to locate a patient's body in 3D space. It is calibrated to the patient's original position immediately prior to the surgery so any movement is tracked and the patient can be returned to the original position at any time during or after the surgery.
RADLINK, INC.
SENSOR
In Commercial Distribution

  • 00866389000174 ()


  • Electronic goniometer/kinesiology sensor
The wireless Enfasmart FeverSense Continuous Monitoring Thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
VIVALNK, INC.
VV220
In Commercial Distribution

  • 00865064000164 ()


  • Wireless patient thermometer, reusable
The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
VIVALNK, INC.
VV200
In Commercial Distribution

  • 00865064000119 ()


  • Wireless patient thermometer, reusable
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
A clinical information system with a digital goniometer. The system can be configured to have diagnostic functionality but does not allow or enable direct diagnosis. No decisive information for making a diagnosis can be provided by the system on its own and it cannot provide diagnosis by itself, nor does it perform as a clinician or provide an indicative diagnosis to the lay user.
FUTURE HEALTH WORKS LTD
MD
In Commercial Distribution

  • G333KQX001 ()


  • Electronic goniometer/kinesiology sensor
A device to assist the clinician with establishing an objective assessment of a person’s range of movement. The device is intended to be non-invasive, non-surgical and transient.
JTECH Medical
9RF408
In Commercial Distribution

  • G0419RF4080 ()


  • Electronic goniometer/kinesiology sensor
A device to assist the clinician with establishing an objective assessment of a person’s range of movement. The device is intended to be non-invasive, non-surgical and transient.
JTECH Medical
9RF404
In Commercial Distribution

  • G0419RF4040 ()


  • Electronic goniometer/kinesiology sensor
A device to assist the clinician with establishing an objective assessment of a person’s range of movement. The device is intended to be non-invasive, non-surgical and transient.
JTECH Medical
9RF403
In Commercial Distribution

  • G0419RF4030 ()


  • Electronic goniometer/kinesiology sensor
A device to assist the clinician with establishing an objective assessment of a person’s range of movement. The device is intended to be non-invasive, non-surgical and transient.
JTECH Medical
9RF308
In Commercial Distribution

  • G0419RF3080 ()


  • Electronic goniometer/kinesiology sensor
A device to assist the clinician with establishing an objective assessment of a person’s range of movement. The device is intended to be non-invasive, non-surgical and transient.
JTECH Medical
9RF304
In Commercial Distribution

  • G0419RF3040 ()


  • Electronic goniometer/kinesiology sensor
A device to assist the clinician with establishing an objective assessment of a person’s range of movement. The device is intended to be non-invasive, non-surgical and transient.
JTECH Medical
9RF303
In Commercial Distribution

  • G0419RF3030 ()


  • Electronic goniometer/kinesiology sensor
A device to assist the clinician with establishing an objective assessment of a person’s range of movement. The device is intended to be non-invasive, non-surgical and transient.
JTECH Medical
9CM114
In Commercial Distribution

  • G0419CM1140 ()


  • Electronic goniometer/kinesiology sensor
A device to assist the clinician with establishing an objective assessment of a person’s range of movement. The device is intended to be non-invasive, non-surgical and transient.
JTECH Medical
9CM113
In Commercial Distribution

  • G0419CM1130 ()


  • Electronic goniometer/kinesiology sensor
A wearable, battery-powered, electronic device intended to continuously measure body temperature and wirelessly transmit data to a computing device, typically a smartphone or tablet with dedicated software, for recording and data display; it is typically used to monitor temperature during daily activities and sleep. It is in the form of an adhesive patch designed to be placed on the skin (typically in/near the armpit); a charging case and software may be included. This is a reusable device.
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
KD-3120.CVS
In Commercial Distribution

  • 40050428459506 ()
  • 00050428459508 ()


  • 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
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