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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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WELL-LIFE - 04719872260028

The Well Life Self Adhesive Electrode / CM, FA, PU and SP series are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Well Life Self Adhesive Electrode / CM, FA, PU and SP series are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS, EMS, IF, and PGS.
WELL-LIFE HEALTHCARE LTD.
CM-5050
In Commercial Distribution

  • 04719872260028 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered

MyoCycle Home/Pro - 00861553000400

FES cycle ergometer
MYOLYN, LLC
MC-HP-1
In Commercial Distribution

  • 00861553000400 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered

NeoTone - 00864618000360

Treatment Table, NeoTone ExMI PRO Plus
MAGIC RACE LLC
N-0242-T
In Commercial Distribution

  • 00864618000360 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered

NeoTone - 00864618000353

Treatment Head, NeoTone ExMI PRO
MAGIC RACE LLC
N-0242-B
In Commercial Distribution

  • 00864618000353 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered

NeoTone - 00864618000346

Control Unit, 110 volt, NeoTone ExMI
MAGIC RACE LLC
N-0243-B-110VAC
In Commercial Distribution

  • 00864618000346 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered

NeoTone - 00864618000339

Control Unit, 220 volt, NeoTone ExMI
MAGIC RACE LLC
N-0243-B-220VAC
In Commercial Distribution

  • 00864618000339 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered

NeoControl - 00864618000322

Treatment Chair, NeoControl Pelvic Floor Therapy System
MAGIC RACE LLC
N-0227-A
In Commercial Distribution

  • 00864618000322 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered

NeoControl - 00864618000315

Control Unit, 110 volt, NeoControl Pelvic Floor Therapy System
MAGIC RACE LLC
N-0228-G-110VAC
In Commercial Distribution

  • 00864618000315 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered

NeoControl - 00864618000308

Control Unit, 220 volt, NeoControl Pelvic Floor Therapy System
MAGIC RACE LLC
N-0228-F-220VAC
In Commercial Distribution

  • 00864618000308 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered

ReBuilder - 00866650000308

Stimulator, nerve, transcutaneous, for pain relief. The ReBuilder is an intelligent medical device that relieves chronic pain by calming erratic nerve signals, strengthening muscles, and restoring local blood flow.
REBUILDER MEDICAL INC.
2407
In Commercial Distribution

  • 00866650000308 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
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