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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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The MyoPro, 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 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 multi-articulating wrist (MAW), a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station. The MyoPro’s EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 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.
Motion E Left - 25744
In Commercial Distribution

  • 00855846007047 ()
25744

  • Psychophysiological biofeedback system
  • Elbow orthosis
  • Hand orthosis
The MyoPro, 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 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 multi-articulating wrist (MAW), a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station. The MyoPro’s EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 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.
Motion W Right - 25742
In Commercial Distribution

  • 00855846007030 ()
25742

  • Psychophysiological biofeedback system
  • Elbow orthosis
  • Hand orthosis
The MyoPro, 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 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 multi-articulating wrist (MAW), a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station. The MyoPro’s EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 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.
Motion W Left - 25738
In Commercial Distribution

  • 00855846007023 ()
25738

  • Psychophysiological biofeedback system
  • Elbow orthosis
  • Hand orthosis
The MyoPro, 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 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 multi-articulating wrist (MAW), a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station. The MyoPro’s EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 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.
Motion G Right - 25740
In Commercial Distribution

  • 00855846007016 ()
25740

  • Psychophysiological biofeedback system
  • Elbow orthosis
  • Hand orthosis
The MyoPro, 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 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 multi-articulating wrist (MAW), a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station. The MyoPro’s EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 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.
Motion G Left - 25736
In Commercial Distribution

  • 00855846007009 ()
25736

  • Psychophysiological biofeedback system
  • Elbow orthosis
  • Hand orthosis
BeamSite™ is a camera system that enables live visualization of the treatment beam on a patient during radiotherapy. It is an optically based system that is non-patient contacting and produces no radiation. When the treatment beam is on, BeamSite captures images of Cherenkov light emitted from the patient’s skin during radiotherapy to provide an optical map of the treatment beam on the patient. When the treatment beam is off, the system provided continuous background images of the treatment area under ambient light illumination. The BeamSite system consists of a camera, a workstation with preinstalled BeamSite software, and a monitor to be used by clinical radiotherapy teams to a) visually observe the patient and the Cherenkov light emitted from irradiated surface anatomy, and b) review the treatment images, if necessary.
Doseoptics LLC
BeamSite
In Commercial Distribution

  • 00860009184503 ()


  • Radiation therapy software
  • Radiation therapy system workstation, multi-purpose
Brand Name: PlaDuo PRO System (PlaDuo System) Model: PlaDuo PRO System
shenb Co., Ltd.
PlaDuo PRO System
In Commercial Distribution

  • 08800017101422 ()


  • Nitrogen plasma skin surface treatment system
  • Argon-enhanced electrosurgical system gas delivery unit
No Description
shenb Co., Ltd.
PlaDuo
In Commercial Distribution

  • 08800017101118 ()


  • Nitrogen plasma skin surface treatment system
  • Argon-enhanced electrosurgical system gas delivery unit
ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options.
IMMERSIVETOUCH, INC.
ImmersiveTouch4
In Commercial Distribution

  • B940IVZBKIT0 ()


  • Portable computer
TigerView software version 8.4.1
TELEVERE SYSTEMS, LLC
8.4.1
In Commercial Distribution

  • 00851800007108 ()
TigerView 8.4.1

  • Basic diagnostic x-ray system application software
  • Camera application software
  • Multidisciplinary medical image management software
  • General-purpose dental x-ray system application software
  • Radiological PACS software
TigerView software version 8.2
TELEVERE SYSTEMS, LLC
8.2
In Commercial Distribution

  • 00851800007085 ()
TigerView 8.2

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Multidisciplinary medical image management software
  • Camera application software
  • Basic diagnostic x-ray system application software
ExamVue PACS version 1.1 Build 81
TELEVERE SYSTEMS, LLC
1.1 Build 81
In Commercial Distribution

  • 00851800007078 ()
ExamVue PACS 1.1 Build 81

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Multidisciplinary medical image management software
  • Camera application software
  • Basic diagnostic x-ray system application software
TigerView software version 8.3
TELEVERE SYSTEMS, LLC
8.3
In Commercial Distribution

  • 00851800007061 ()
TigerView 8.3

  • Basic diagnostic x-ray system application software
  • Camera application software
  • Multidisciplinary medical image management software
  • General-purpose dental x-ray system application software
  • Radiological PACS software
TigerView Pro software version 7.7.3
TELEVERE SYSTEMS, LLC
7.7.3
In Commercial Distribution

  • 00851800007023 ()
TigerView Pro 7.7.3

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Multidisciplinary medical image management software
  • Camera application software
  • Basic diagnostic x-ray system application software
TigerView 8.1 software Build 81
TELEVERE SYSTEMS, LLC
8.1 Build 81
In Commercial Distribution

  • 00851800007016 ()
TigerView 8.1 Build 81

  • Basic diagnostic x-ray system application software
  • Camera application software
  • Multidisciplinary medical image management software
  • General-purpose dental x-ray system application software
  • Radiological PACS software
TigerView Pro software version 7.7.13
TELEVERE SYSTEMS, LLC
7.7.13
In Commercial Distribution

  • 00851800007009 ()
TigerView Pro 7.7.13

  • Radiological PACS software
  • General-purpose dental x-ray system application software
  • Multidisciplinary medical image management software
  • Camera application software
  • Basic diagnostic x-ray system application software
Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS Software Kit, BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit
BIONESS INC.
BITS-3055
In Commercial Distribution

  • 00815962020610 ()


  • Perceptual-coordination assistive training device
HDi System Overpack, with ACIST Connect, JAPAN p/n 801081-001 Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply, ACI Hardware
ACIST MEDICAL SYSTEMS, INC.
016323
Not in Commercial Distribution

  • 40841716102057 ()


  • Cardiovascular ultrasound imaging system
RecordConnect Module Recording System Connector
ST. JUDE MEDICAL, INC.
H421088
In Commercial Distribution

  • 05414734210881 ()
H421088

  • Electrical-only medical device connection cable, reusable
  • Cardiac mapping system
No Description
ULTROMICS LIMITED
Pro
In Commercial Distribution

  • 05060634690010 ()


  • Ultrasound imaging system application software
  • Cardiac mapping system application software
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