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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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Modus Health LLC
StepWatch5
In Commercial Distribution

  • 00860007307515 ()


  • Kinesiology ambulatory recorder
Wearable Gait Sensors, Pair
StrideLink Inc.
1
In Commercial Distribution

  • 00860010613320 ()


  • Kinesiology ambulatory recorder
The ActiGraph LEAP™ is a small, worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring. The device is intended to monitor the activity associated with movement during sleep. The ActiGraph LEAP™ can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.
ACTIGRAPH L.L.C.
LEAP
In Commercial Distribution

  • 00853048008053 ()
LEAP

  • Kinesiology ambulatory recorder
The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable activity recording device with physical characteristics similar to those of a small wristwatch. The watch is intended to acquire and store data from an onboard accelerometer while being worn during normal activities and/or during sleep. The data record is timestamped and stored in non-volatile memory for later retrieval. Downloaded data can be post-processed based on the timestamp and magnitude of acceleration along each axis. The housing is constructed of a combination of opaque and clear copolyesters formulated specifically for medical devices (i.e., tested and determined biocompatible), and the core data collection sensor is a 3-axis microelectromechanical system (MEMS) accelerometer. A charging dock connected to a USB power source is used to charge the device battery and communicate with a PC or peripheral.
ACTIGRAPH L.L.C.
CentrePoint Insight Watch
In Commercial Distribution

  • 00853048008039 ()
CPW01

  • Kinesiology ambulatory recorder
The GT9X is a body worn device that measures and records physical movement associated with daily activity and sleep. The GT9X is intended for use in applications where quantifiable measurement and storage of physical movement is desired.
ACTIGRAPH L.L.C.
GT9X
In Commercial Distribution

  • 00853048008015 ()


  • Kinesiology ambulatory recorder
The wGT3X-BT is a body worn device that measures and records physical movement associated with daily activity and sleep. The wGT3X-BT is intended for use in applications where quantifiable measurement and storage of physical movement is desired.
ACTIGRAPH L.L.C.
wGT3X-BT
In Commercial Distribution

  • 00853048008008 ()


  • Kinesiology ambulatory recorder
The Opal DataHub V2C is an accessory that extracts raw sensor data from the Opal V2C sensors and uploads it to a remote server where the files are processed. Additionally, the Opal DataHub recharges the battery of the Opal V2C sensors.
APDM WEARABLE TECHNOLOGIES, INC.
DataHub
In Commercial Distribution

  • 00850067173038 ()


  • Kinesiology ambulatory recorder
Access Point V2C is an accessory that enables wireless streaming to a computer for the Opal V2C.
APDM WEARABLE TECHNOLOGIES, INC.
AP
In Commercial Distribution

  • 00850067173021 ()


  • Kinesiology ambulatory recorder
Docking Station V2C is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, the Docking Station recharges the battery of an Opal V2C.
APDM WEARABLE TECHNOLOGIES, INC.
DOCK
In Commercial Distribution

  • 00850067173014 ()


  • Kinesiology ambulatory recorder
Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monitoring. The Opal V2C can be used in any instance where quantifiable analysis of physical motion is desirable.
APDM WEARABLE TECHNOLOGIES, INC.
Opal V2C
In Commercial Distribution

  • 00850067173007 ()


  • Kinesiology ambulatory recorder
The DataLOG is the latest in data acquisition technology developed to meet the needs of researchers for portable data collection and monitoring in human performance, sports science, medical research, industrial ergonomics, gait laboratories, and educational settings. Includes: 8 channel data acquisition unit, Bluetooth adapter, 6 x Micro SD cards, Card reader, Management Software, instrument case This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
BIOMETRICS LIMITED
MWX8
In Commercial Distribution

  • 05060481691789 ()
MWX8 DataLOG - metal connectors

  • Kinesiology ambulatory recorder
The Biometrics Analysis Software is a comprehensive tool for EMG, Goniometer and associated sensor analysis including real-time data analysis as the data is collected. The Analysis software also contains all of the features of the Management Software: The DataLOG Management Software allows the user to set up the DataLOG communications with the computer, configure the sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data Software is available in English, Chinese, and Japanese.
BIOMETRICS LIMITED
410xx-11
In Commercial Distribution

  • 05060481691680 ()


  • Kinesiology ambulatory recorder
The DataLOG Management Software allows the user to set up the DataLOG communications with the computer, configure the sensors, collect and save the data. the Management software also contains the Dynamic Link Library for streaming data to third party software. Software is available in English, Chinese, and Japanese.
BIOMETRICS LIMITED
410xx-00
In Commercial Distribution

  • 05060481691673 ()


  • Kinesiology ambulatory recorder
The DataLOG is the latest in data acquisition technology developed to meet the needs of researchers for portable data collection and monitoring in human performance, sports science, medical research, industrial ergonomics, gait laboratories, and educational settings. Includes: 8 channel data acquisition unit, Bluetooth adapter, 6 x Micro SD cards, Card reader, Management Software, instrument case This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
MWX8
In Commercial Distribution

  • 05060481691666 ()
MWX8 DataLOG - plastic connectors

  • Kinesiology ambulatory recorder
X4 KNEE BRACE, LT, UNIV, BLK
DJO, LLC
11-4001-0-06000
In Commercial Distribution

  • 00190446286974 ()

  • UNIV


  • Kinesiology ambulatory recorder
X4 KNEE BRACE, RT, UNIV, BLK
DJO, LLC
11-4000-0-06000
In Commercial Distribution

  • 00190446286967 ()

  • UNIV


  • Kinesiology ambulatory recorder
MOTION INTELLIGENCE APP
DJO, LLC
13-4024
In Commercial Distribution

  • 00190446293613 ()

  • UNIV


  • Kinesiology ambulatory recorder
APDM's Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monitoring. The Opal V2C can be used in any instance where quantifiable analysis of physical motion is desirable.
APDM, INC.
V2C
In Commercial Distribution

  • B628OPALV2C0 ()
OPALV2C

  • Kinesiology ambulatory recorder
APDM’s Docking Station is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, the Docking Station recharges the battery of an Opal V2C.
APDM, INC.
V2C
In Commercial Distribution

  • B628DSV2C0 ()
DSV2C

  • Kinesiology ambulatory recorder
APDM’s Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.
APDM, INC.
V2C
In Commercial Distribution

  • B628APV2C0 ()
APV2C

  • Kinesiology ambulatory recorder
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