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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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Healing Innovations - 00860003483206

robotic neurorehabilitation device for gait training and additional therapy purposes
Healing Innovations, Inc.
RWC1000
In Commercial Distribution

  • 00860003483206 ()


  • Gait rehabilitation frame, electric

Magnetic Shield - 00862563003191

Magnetic shield for the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003191 ()
403350

  • Intraurethral valve/pump

Activator Kit - 00862563003184

Magnetic remote control for the inFlow Device - with base station and medical charger
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003184 ()
403507K

  • Intraurethral valve/pump

Medical Charger - 00862563003177

Recharger for inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003177 ()
403320

  • Intraurethral valve/pump

Base Station - 00862563003160

Unit for storing and recharging the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003160 ()
403310

  • Intraurethral valve/pump

Activator - 00862563003153

Magnetic remote control for the inFlow Device
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003153 ()
403300

  • Intraurethral valve/pump

E-Pacer - 00858101008292

Powered gait trainer and transfer device
RIFTON EQUIPMENT
K660
In Commercial Distribution

  • 00858101008292 ()


  • Gait rehabilitation electronic walker

XL Pacer - 00858101008285

Gait Trainer
RIFTON EQUIPMENT
K650
In Commercial Distribution

  • 00858101008285 ()


  • Gait rehabilitation frame, manual

Large Pacer - 00858101008278

Gait Trainer
RIFTON EQUIPMENT
K640
In Commercial Distribution

  • 00858101008278 ()


  • Gait rehabilitation frame, manual

Medium Pacer - 00858101008261

Gait Trainer
RIFTON EQUIPMENT
K630
In Commercial Distribution

  • 00858101008261 ()


  • Gait rehabilitation frame, manual
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