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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. 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
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 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 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
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
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