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 ReoAmbulator model is robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The ReoAmbulator enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
B
In Commercial Distribution

  • 07290017844305 ()
RA01-0000-00

  • Gait rehabilitation system harness
Prometra II 40ml Programmable Pump
Flowonix Medical, Inc.
16827
In Commercial Distribution

  • 00810335020242 ()


  • Implantable intrathecal infusion pump, programmable
The Prometra II Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter. To help increase safety, the Prometra II Pump incorporates a safety valve (flow-activated valve or FAV) that will shut off drug flow to the patient in the event a high flow rate occurs, such as during an MRI. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. The Prometra II Pump contains a metal bellows drug reservoir with a capacity of 20 milliliters (mL). The reservoir propellant is stored within the rigid housing surrounding the bellows and provides the driving pressure for the pump. The driving pressure on the reservoir forces the infusate through an outlet filter (0.22 pm), and into an electronically controlled flow metering valve-accumulator subsystem. The Infumorph passes from the flow metering subsystem, into the catheter access port then into the catheter for delivery to the intrathecal space.
Flowonix Medical, Inc.
13827
In Commercial Distribution

  • 00810335020228 ()


  • Implantable intrathecal infusion pump, programmable
The Prometra Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter.
Flowonix Medical, Inc.
11827
In Commercial Distribution

  • 00810335020082 ()


  • Implantable intrathecal infusion pump, programmable
Refill Kit
Medos International Sàrl
91-4287
In Commercial Distribution

  • 10886704072072 ()
914287

  • Implantable intrathecal infusion pump, programmable
Refill Kit
Codman Neuro Sciences Sàrl
91-4285US
In Commercial Distribution

  • 20886704071454 ()
  • 10886704071457 ()
914285US

  • Implantable intrathecal infusion pump, programmable
Bolus Kit
Medos International Sàrl
91-4284US
In Commercial Distribution

  • 10886704071440 ()
914284US

  • Implantable intrathecal infusion pump, programmable
PUMP 8637-40 SM II 40ML EMAN SYMBL GRC
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00763000422615 ()


  • Implantable intrathecal infusion pump, programmable
PUMP 8637-20 SM II 20ML EMAN SYMBL GRC
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00763000422608 ()


  • Implantable intrathecal infusion pump, programmable
PUMP 8637-40 SM II 40ML EMAN SYMBL
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00763000634100 ()

  • Reservoir Volume 40 ML


  • Implantable intrathecal infusion pump, programmable
PUMP 8637-20 SM II 20ML EMAN SYMBL
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00763000634094 ()

  • Reservoir Volume 20 ML


  • Implantable intrathecal infusion pump, programmable
PUMP 8667-40 SYNCHROMEDIII INFUSION EMAN
MEDTRONIC, INC.
8667-40
In Commercial Distribution

  • 00763000597030 ()

  • Reservoir Volume 40 mL


  • Implantable intrathecal infusion pump, programmable
PUMP 8667-20 SYNCHROMEDIII INFUSION EMAN
MEDTRONIC, INC.
8667-20
In Commercial Distribution

  • 00763000597023 ()

  • Reservoir Volume 20 mL


  • Implantable intrathecal infusion pump, programmable
Gait rehabilitation system harness
Liko AB
3666006
In Commercial Distribution

  • 00887761984110 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3666005
In Commercial Distribution

  • 00887761984103 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3666004
In Commercial Distribution

  • 00887761984097 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564118
In Commercial Distribution

  • 00887761983847 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564117
In Commercial Distribution

  • 00887761983830 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564116
In Commercial Distribution

  • 00887761983823 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564115
In Commercial Distribution

  • 00887761983816 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3564114
In Commercial Distribution

  • 00887761983809 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560118
In Commercial Distribution

  • 00887761983793 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560117
In Commercial Distribution

  • 00887761983786 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560116
In Commercial Distribution

  • 00887761983779 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560115
In Commercial Distribution

  • 00887761983762 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560114
In Commercial Distribution

  • 00887761983755 ()


  • Gait rehabilitation system harness
Gait rehabilitation system harness
Liko AB
3560113
In Commercial Distribution

  • 00887761983748 ()


  • Gait rehabilitation system harness
Refill Kit
Medos International Sàrl
91-4288
In Commercial Distribution

  • 20886704064951 ()
  • 10886704064954 ()
914288

  • Implantable intrathecal infusion pump, programmable
Unloading harness for gait training
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRUHS0 ()


  • Gait rehabilitation system harness
Bariatric Harness for persons 300-600 lbs
M.A.S.S. Rehab, LLC
Bariatric
In Commercial Distribution

  • G505MRUHB0 ()


  • Gait rehabilitation system harness
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