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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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A moving cart holding a processing unit/computer (PC) that drives the handheld scanner, power supplies and a display
3shape Trios A/S
TRIOS 3 cart
Not in Commercial Distribution

  • 05902768365504 ()


  • Dental milling system, CAD/CAM, chairside
The PD meter model PM-700 is a pupillary distance meter improved with a built-in computer and LCD digital display.
NIDEK CO.,LTD.
PM-700
In Commercial Distribution

  • 04987669100837 ()


  • Ophthalmodiastimeter
SureSigns VS2+ NBP/SP02
Philips Medical Systems Hsg
863278
In Commercial Distribution

  • 00884838028395 ()
863278

  • General-purpose multi-parameter bedside monitor
SureSigns VSi NBP/SP02/Temp/Wireless
Philips Medical Systems Hsg
863277
In Commercial Distribution

  • 00884838028388 ()
863277

  • General-purpose multi-parameter bedside monitor
SureSigns VSi - NBP/SPO2
Philips Medical Systems Hsg
863276
In Commercial Distribution

  • 00884838028371 ()
863276

  • General-purpose multi-parameter bedside monitor
SureSigns VSi - NBP
Philips Medical Systems Hsg
863275
In Commercial Distribution

  • 00884838028364 ()
863275

  • General-purpose multi-parameter bedside monitor
The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb. The MyoPro 2x Assembly Kit consists of a combination of the following components, some or all of which are not yet assembled: a shoulder harness, a custom-made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set wrist module, a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station. The MyoPro 2x EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 2x filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro 2x to assist the User to initiate and complete desired motions.
Myomo, Inc.
Motion G Right - 30382 rev1
In Commercial Distribution

  • 00855846007252 ()
30382

  • Psychophysiological biofeedback system
  • Elbow orthosis
  • Hand orthosis
The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb. The MyoPro 2x Assembly Kit consists of a combination of the following components, some or all of which are not yet assembled: a shoulder harness, a custom-made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set wrist module, a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station. The MyoPro 2x EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 2x filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro 2x to assist the User to initiate and complete desired motions.
Myomo, Inc.
Motion G Left - 30381 rev1
In Commercial Distribution

  • 00855846007245 ()
30381

  • Psychophysiological biofeedback system
  • Elbow orthosis
  • Hand orthosis
The Mobile Arm Rehabilitation Kit version 2 (MARK2) is a kit containing two (left and right) MyoPro upper extremity limb orthoses. A MyoPro upper extremity limb orthosis is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb. The MARK2 product consists of a combination of the following components: shoulder harnesses, adjustable limb orthoses (braces), powered elbow orthoses with surface electromyography (EMG) sensors, static or manually set multi-articulating wrists (MAW), static hand orthoses or powered hand orthoses with EMG sensors, an interchangeable battery with a separate recharging station, an MTS chafe with loop for anti-rotation strap, a laptop, and a product carrying case/bag. The MyoPro’s EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. A MyoPro device filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro to assist the User to initiate and complete desired motions.
Myomo, Inc.
MARK2 29860
In Commercial Distribution

  • 00855846007238 ()
MARK2 29860

  • Psychophysiological biofeedback system
  • Elbow orthosis
  • Hand orthosis
The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb. The MyoPro 2x consists of a combination of the following components: a shoulder harness, a custom-made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set wrist module, a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station. The MyoPro 2x EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 2x filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro 2x to assist the User to initiate and complete desired motions.
Myomo, Inc.
Motion G Right - 29858 rev1
In Commercial Distribution

  • 00855846007221 ()
29858

  • Psychophysiological biofeedback system
  • Elbow orthosis
  • Hand orthosis
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