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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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
The NeckCare Device is used to measure and record head motion during instructed head-neck movements.
NeckCare Holding ehf
NS-110X2
In Commercial Distribution



  • Electronic goniometer/kinesiology sensor
The NeckCare System is used to measure, record, analyze and report head motion during instructed head-neck movements.
NeckCare Holding ehf
NS-110X2
In Commercial Distribution

  • 05694230564019 ()


  • Electronic goniometer/kinesiology sensor
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 EN 60601-1:1990 including Amendments A1, A2 and A13
BIOMETRICS LIMITED
N200
In Commercial Distribution

  • 05060481692434 ()


  • 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 EN 60601-1:1990 including Amendments A1, A2 and A13
BIOMETRICS LIMITED
N100
In Commercial Distribution

  • 05060481692427 ()


  • Electronic goniometer/kinesiology sensor
Accurate measurements of upper and lower extremity ROM with precise electronic tools for evaluation and progress reporting. The Biometrics Range of Motion Kit (R500) provides precise electronic tools for: upper and lower extremity range of motion measurements
BIOMETRICS LIMITED
R500
In Commercial Distribution

  • 05060481690072 ()


  • Electronic goniometer/kinesiology sensor
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
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
Pair of Lafayette Range of Motion Inclinometers designed for quick wireless connection when taking dual inclinometer measurements. The Lafayette Range of Motion Inclinometer is capable of taking measurements in three different planes. It can record maximal range of motion movements in flexion/extension, rotation, or front to back. An easy-to-read LCD screen displays the real-time angle along with up to six previously recorded measurements.
LAFAYETTE INSTRUMENT COMPANY, INC.
ACU100-DUAL
In Commercial Distribution

  • 00855170007416 ()
ACU100-DUAL

  • Electronic goniometer/kinesiology sensor
The Lafayette Range of Motion Inclinometer is a wireless digital goniometer/inclinometer that is capable of taking measurements in three different planes. It can record maximal range of motion movements in flexion/extension, rotation, or front to back. An easy-to-read LCD screen displays the real-time angle along with up to six previously recorded measurements. Capable of wireless communication with a second unit for dual inclinometer joint measurements.
LAFAYETTE INSTRUMENT COMPANY, INC.
ACU100
In Commercial Distribution

  • 00855170007409 ()
ACU100

  • Electronic goniometer/kinesiology sensor
No Description
Canary Medical USA LLC
43-5570-007-14
In Commercial Distribution

  • 00860003118344 ()


  • Electronic goniometer/kinesiology sensor
Battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint
Rom Technologies, Inc
28000
In Commercial Distribution

  • 00860002828701 ()
28000

  • 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 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
K Move 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 BIOMECANIQUE
K Move V3
In Commercial Distribution

  • 03770011995462 ()


  • Electronic goniometer/kinesiology sensor
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
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
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
JIMI System
ARTHREX, INC.
AR-1535S
Not in Commercial Distribution

  • 00888867306721 ()
AR-1535S

  • 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
MotionSense Application Version 1.5
ENMOVI LTD
SW-1.5-MSAPP
In Commercial Distribution

  • 55060808320168 ()
SW-1.5-MSAPP

  • Electronic goniometer/kinesiology sensor
MotionSense Application Version 1.4
ENMOVI LTD
SW-1.4-MSAPP
In Commercial Distribution

  • 55060808320151 ()
SW-1.4-MSAPP

  • Electronic goniometer/kinesiology sensor
OrthoLogIQ PT Version 1.0
ENMOVI LTD
SW-1.0-OIQPT
Not in Commercial Distribution

  • 55060808320120 ()
SW-1.0-OIQPT

  • Electronic goniometer/kinesiology sensor
MotionSense Application Version 1.3
ENMOVI LTD
SW-1.3-MSAPP
In Commercial Distribution

  • 55060808320076 ()
SW-1.3-MSAPP

  • Electronic goniometer/kinesiology sensor
No Description
ENMOVI LTD
MotionSense 2.0
In Commercial Distribution

  • 55060808320007 ()
007-00036-US

  • Electronic goniometer/kinesiology sensor
Respiration Sensor All Around Strap
XACT ROBOTICS LTD
A
In Commercial Distribution

  • 17290017702220 ()
  • 07290017702223 ()
XR-RS-AAS

  • Electronic goniometer/kinesiology sensor
MotionSense Knee Alignment Block
ENMOVI LTD
007-00068-US
In Commercial Distribution

  • 15060808320115 ()
007-00068-US

  • Electronic goniometer/kinesiology sensor
MotionSense Adhesive Refill Kit
ENMOVI LTD
007-00067-US
In Commercial Distribution

  • 15060808320108 ()
007-00067-US

  • Electronic goniometer/kinesiology sensor
MotionSense Digital Goniometer
ENMOVI LTD
007-00066-US
In Commercial Distribution

  • 15060808320092 ()
007-00066-US

  • Electronic goniometer/kinesiology sensor
No Description
ENMOVI LTD
MotionSense 2.0
In Commercial Distribution

  • 15060808320030 ()
007-00038-US

  • Electronic goniometer/kinesiology sensor
No Description
ENMOVI LTD
MotionSense 2.0
In Commercial Distribution

  • 15060808320023 ()
007-00037-US

  • Electronic goniometer/kinesiology sensor
CORI KNEE TENSIONER
Smith & Nephew, Inc.
ROB10100
In Commercial Distribution

  • 00885556809600 ()
ROB10100

  • Orthopaedic knee-balance analyser, electrically-powered
This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1TB
In Commercial Distribution

  • 04547410389005 ()


  • Computer/medical device keyboard
This product is intended to be used in combination with FUJIFILM ultrasonic processor SU-1 PLATINUM/SU-1 to operate the processor's functions. Do not use this product for any other purpose.
FUJIFILM CORPORATION
CP-1
In Commercial Distribution

  • 04547410388992 ()


  • Computer/medical device keyboard
XVI Cassette F0
ELEKTA LIMITED
1527278
In Commercial Distribution

  • 05060191071208 ()


  • Radiation therapy digital imager
XVI Cassette M10
ELEKTA LIMITED
1526927
In Commercial Distribution

  • 05060191071192 ()


  • Radiation therapy digital imager
XVI Cassette L20
ELEKTA LIMITED
1526926
In Commercial Distribution

  • 05060191071185 ()


  • Radiation therapy digital imager
XVI Cassette M20
ELEKTA LIMITED
1526925
In Commercial Distribution

  • 05060191071178 ()


  • Radiation therapy digital imager
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