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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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RadQual - 00850020470037

Square Digirad Phantom Co 57
RADQUAL, LLC
BM05
In Commercial Distribution

  • 00850020470037 ()


  • Nuclear medicine phantom, flood source

RadQual - 00850020470020

Rect 14" x 18" Phantom Co 57
RADQUAL, LLC
BM04
In Commercial Distribution

  • 00850020470020 ()


  • Nuclear medicine phantom, flood source

RadQual - 00850020470006

Rect 18" x24" Phantom Co 57
RADQUAL, LLC
BM01
In Commercial Distribution

  • 00850020470006 ()


  • Nuclear medicine phantom, flood source

Steadys-Step - 04650075332078

System is intended for objective gait analysis and biofeedback gait training based on EMG and IMU (Inertial Measurement Unit) data obtained with inertial sensors.
NEUROSOFT, OOO
Steadys-Step
In Commercial Distribution

  • 04650075332078 ()


  • Kinesiology/electromyographic sensor set

E-LINK Myo-EX GX2 EMG Sensor - 05060481692458

Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX2 sensor is used with disposable/reusable electrodes and applied where there is need to cover a larger surface area, for example on the quad muscles.. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
BIOMETRICS LIMITED
GX2
In Commercial Distribution

  • 05060481692458 ()


  • Kinesiology/electromyographic sensor set

E-LINK Myo-EX GX1 EMG Sensor - 05060481692441

Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX1 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
BIOMETRICS LIMITED
GX1
In Commercial Distribution

  • 05060481692441 ()


  • Kinesiology/electromyographic sensor set

E-LINK Myo-EX GX4 EMG Sensor - 05060481690515

Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX4 sensor is used with disposable/reusable electrodes and applied where there is need to cover a larger surface area, for example on the quad muscles.. Metal connector for use with E-LINK X4 MkI or MkII Interface Unit with metal connectors. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
BIOMETRICS LIMITED
GX4
In Commercial Distribution

  • 05060481690515 ()
GX4 metal connector

  • Kinesiology/electromyographic sensor set

E-LINK Myo-EX GX3 EMG Sensor - 05060481690508

Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX3 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape. Metal connector for use with E-LINK X4 MkI or MkII Interface Unit with metal connectors. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
BIOMETRICS LIMITED
GX3
In Commercial Distribution

  • 05060481690508 ()
GX3 metal connector

  • Kinesiology/electromyographic sensor set

E-LINK Myo-EX GX5 Wireless EMG Sensor - 05060481690157

Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX5 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
GX5
In Commercial Distribution

  • 05060481690157 ()


  • Kinesiology/electromyographic sensor set

E-LINK Myo-EX GX4 EMG Sensor - 05060481690119

Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX4 sensor is used with disposable/reusable electrodes and applied where there is need to cover a larger surface area, for example on the quad muscles.. Plastic connector for use with E-LINK X4 MkIV Interface Unit with plastic connectors. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
GX4
In Commercial Distribution

  • 05060481690119 ()
GX4 plastic connector

  • Kinesiology/electromyographic sensor set
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