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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 Reprieve by Regenesis device is a home-use shortwave diathermy (SWD) device that can be programmed to either a continuous wave (CW) mode or a pulsed wave (PW) mode at manufacture (not programmable by the user). The Reprieve by Regenesis SWD device includes a base control unit, one or two treatment applicators, and an external power supply. The base control unit and treatment applicator(s) are enclosed in an injection-molded case made of medical grade poly carbonate. The treatment applicator(s) and power supply are attached to the base control unit. When not in use, the control unit acts as its own carrying case with the treatment applicators stored a slot in the Control Unit, the power supply stored in an attached pouch behind the control unit, and the treatment applicator cables stored using an attached cable management loop. The Reprieve by Regenesis SWD device is indicated to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
Regenesis Biomedical, Inc.
A
In Commercial Distribution

  • 00868924000038 ()


  • Short-wave diathermy treatment system, home-use
Light Weight Wheelchair
Bowhead Design Corporation
A
In Commercial Distribution

  • 00860013500900 ()


  • Push-rim manual wheelchair, non-bariatric
InnoVoyce VYLO Cart
Innovoyce LLC
A
In Commercial Distribution

  • 00860011812180 ()
LC-00455

  • General/multiple surgical diode laser system
InnoVoyce VYLO Footswitch
Innovoyce LLC
A
In Commercial Distribution

  • 00860011812111 ()
PRT-301009

  • General/multiple surgical diode laser system
InnoVoyce VYLO Eye Safety Filter Zeiss
Innovoyce LLC
A
In Commercial Distribution

  • 00860011812104 ()
ASY-300144

  • General/multiple surgical diode laser system
To provide support for a patient’s head in the prone position.
ADEPT MEDICAL LIMITED
A
In Commercial Distribution

  • 09421905187718 ()
AM0710

  • Operating table patient positioning set, reusable
Head Immobiliser Hood Assembly and Strap
ADEPT MEDICAL LIMITED
A
In Commercial Distribution

  • 09421905187657 ()
AM0820

  • Operating table patient positioning set, reusable
Adducted Arm Scoop
ADEPT MEDICAL LIMITED
A
In Commercial Distribution

  • 09421905187640 ()
AM1100

  • Radiological arm/leg positioner
To support the Clinicians arm during endoscope guided surgery.
ADEPT MEDICAL LIMITED
A
In Commercial Distribution

  • 09421905187619 ()
AM0900

  • Operator armrest
Head Immobiliser
ADEPT MEDICAL LIMITED
A
In Commercial Distribution

  • 09421905187602 ()
AM0800

  • Operating table patient positioning set, reusable
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