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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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Digital Vital Sign Monitoring System (with two Pediatric Oximeter Sensor Cables), RX ONLY
AULISA MEDICAL USA, INC.
GA1000Rx-P
In Commercial Distribution

  • 14719872650109 ()
  • 04719872650102 ()


  • Pulse oximetry telemetric monitoring system
Digital Vital Sign Monitoring System (with two Adult Oximeter Sensor Cables), RX ONLY
AULISA MEDICAL USA, INC.
GA1000Rx-A
In Commercial Distribution

  • 14719872650093 ()
  • 04719872650096 ()


  • Pulse oximetry telemetric monitoring system
Digital Vital Sign Monitoring System (with two Pediatric Oximeter Sensor Cables), RX ONLY
AULISA MEDICAL USA, INC.
GA1000-P
Not in Commercial Distribution

  • 14719872650062 ()
  • 04719872650065 ()


  • Pulse oximetry telemetric monitoring system
Model WL-2407Rx is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain.
WELL-LIFE HEALTHCARE LTD.
WL-2407Rx
Not in Commercial Distribution

  • 04719872264088 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
● It is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. ● OTC TENS, Patch type.
WELL-LIFE HEALTHCARE LTD.
WL-2406
Not in Commercial Distribution

  • 04719872264064 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
OTC Mini Patch, models: WL-2301A & WL-2301B Transcutaneous Electrical Nerve Stimulators and intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
WELL-LIFE HEALTHCARE LTD.
WL-2301
Not in Commercial Distribution

  • 04719872263012 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
● Well-Life Digital TENS/EMS stimulator, prescription device . ● Intended for symptomatic relief of chronic intractable pain (TENS), and EMS intended for: Relax muscle spasms/ Prevent or retard disuse atrophy/ Increase local blood circulation/ Re-educate muscles/ Maintain or increase the range of motion
WELL-LIFE HEALTHCARE LTD.
WL-2204
Not in Commercial Distribution

  • 04719872262046 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
 Well-Life Powered Muscle Stimulator , analog type.  Intended for: • Relax muscle spasms • Prevent or retard disuse atrophy • Increase local blood circulation • Re-educate muscles • Maintain or increase the range of motion
WELL-LIFE HEALTHCARE LTD.
WL-2104
Not in Commercial Distribution

  • 04719872261049 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
Well-Life Analog electrical nerve stimulator , with BCM mode, and timer ( optional) . Intended for symptomatic relief of chronic intractable pain.
WELL-LIFE HEALTHCARE LTD.
WL-2102
Not in Commercial Distribution

  • 04719872261025 ()


  • Physical therapy transcutaneous electrical stimulation system, line-powered
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
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