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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 medical device Tech in Motion® includes the following parts: • A camera to detect trackers positions through infra-red emission. • A specific software solution installed on a touchscreen PC that allows the visualisation of 3D dental models in motion. • A set of trackers intended to be placed on the patient’s head and in patient’s mouth. • A pen tracker used by the dentist to acquire trackers positions (infrared communication to the camera then transferred to a dedicated software). • An operational cart designed to hold and position the camera and the touchscreen panel PC. The camera is mounted on the cart in right-handed configurations.
MODJAW
TIM US
In Commercial Distribution

  • 03770022347250 ()


  • Jaw physiology evaluation system
The medical device Tech in Motion® includes the following parts: • A camera to detect trackers positions through infra-red emission. • A specific software solution installed on a touchscreen PC that allows the visualisation of 3D dental models in motion. • A set of trackers intended to be placed on the patient’s head and in patient’s mouth. • A pen tracker used by the dentist to acquire trackers positions (infrared communication to the camera then transferred to a dedicated software). • An operational cart designed to hold and position the camera and the touchscreen panel PC. The camera is mounted on the cart in right-handed configurations.
MODJAW
TIMR
In Commercial Distribution

  • 03770022347014 ()
Tech In Motion

  • Jaw physiology evaluation system
The medical device Tech in Motion® includes the following parts: • A camera to detect trackers positions through infra-red emission. • A specific software solution installed on a touchscreen PC that allows the visualisation of 3D dental models in motion. • A set of trackers intended to be placed on the patient’s head and in patient’s mouth. • A pen tracker used by the dentist to acquire trackers positions (infrared communication to the camera then transferred to a dedicated software). • An operational cart designed to hold and position the camera and the touchscreen panel PC. The camera is mounted on the cart in left-handed configurations.
MODJAW
TIML
Not in Commercial Distribution

  • 03770022347007 ()
TIM Left-handed US

  • Jaw physiology evaluation system
The CPRmeter™ CPR feedback device is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim. The feedback is provided in accordance with the 2010 versions of the guidelines for resuscitation published by the International Liaison Committee on Resuscitation (ILCOR), American Heart Association (AHA), and European Resuscitation Council (ERC) (hereinafter referred to as “CPR Guidelines”). The CPRmeter device is intended for use by responders who have been trained in CPR and use of the CPRmeter device. The CPRmeter device provides feedback on CPR via a display panel to improve responders’ compliance with CPR Guidelines.
Laerdal Medical AS
801
Not in Commercial Distribution

  • 07045432055290 ()
801-00149

  • Cardiopulmonary resuscitation feedback device, electronic
The G5® GK-3® Classic is a quiet & powerful Massage Machine designed for rugged use in the office, clinic, school, gym, training room or home. Each GK-3 has a 47 3/4" long, light-weight, smooth drive cable attached to a durable applicator head, to provide greater versatility and ease of use. The GK-3® incorporates a dial-controlled, variable-speed output, with speeds from 20 - 60 cycles per second. This special priced unit comes in our Classic Housing, as pictured. Unit Advantages: Economical Stand Mount or Portable Configurations Basic Control Panel with CPS Indicator (Low, Medium, High) Comes complete with choice of applicator package
GENERAL PHYSIOTHERAPY INC
GK120B
In Commercial Distribution

  • 00746980002022 ()

  • Weight: 34 Pound
GK120B

  • Freestanding electric massager
The G5® GK-3® Classic is a quiet & powerful Massage Machine designed for rugged use in the office, clinic, school, gym, training room or home. Each GK-3 has a 47 3/4" long, light-weight, smooth drive cable attached to a durable applicator head, to provide greater versatility and ease of use. The GK-3® incorporates a dial-controlled, variable-speed output, with speeds from 20 - 60 cycles per second. This special priced unit comes in our Classic Housing, as pictured. Unit Advantages: Economical Stand Mount or Portable Configurations Basic Control Panel with CPS Indicator (Low, Medium, High) Comes complete with choice of applicator package
GENERAL PHYSIOTHERAPY INC
GK 240 B
In Commercial Distribution

  • 00746980001964 ()

  • Weight: 34 Pound
GK240B

  • Freestanding electric massager
The G5® ALC Over-The-Shoulder Massage Machine produces a non-invasive therapy treatment for skin, scalp, tissue, muscles, lymph nodes and the circulatory system. A wide array of applicators combine with the ALC unit to provide aesthetic services such as cellulite reduction, exfoliation, lymphatic drainage, body contouring, skin toning and muscle relaxation. Comes complete with caster stand, accessory tray, and applicators. Unit Advantages: • Versatility: Pole, Table Top • Portability: In-mold handle and smooth casters to easily move from room to room • CPS Indicator on Control Panel • Extra tall stand so cable can hang over the operator’s shoulder for ease of use
GENERAL PHYSIOTHERAPY INC
ALC 240 G5
In Commercial Distribution

  • 00746980001650 ()

  • Weight: 38 Pound
ALC 240 G5

  • Freestanding electric massager
The G5® ALC™ Over-The-Shoulder Massage Machine produces a non-invasive therapy treatment for skin, scalp, tissue, muscles, lymph nodes and the circulatory system. A wide array of applicators combine with the ALC™ unit to provide aesthetic services such as cellulite reduction, exfoliation, lymphatic drainage, body contouring, skin toning and muscle relaxation. Comes complete with caster stand, accessory tray, and applicators. Unit Advantages: • Versatility: Pole, Table Top • Portability: In-mold handle and smooth casters to easily move from room to room • CPS Indicator on Control Panel • Extra tall stand so cable can hang over the operator’s shoulder for ease of use
GENERAL PHYSIOTHERAPY INC
ALC 120 G5
In Commercial Distribution

  • 00746980001582 ()

  • Weight: 38 Pound
ALC 120 G5

  • Freestanding electric massager
The integrated Backup NO delivery system is a completely independent backup NO generating system that is separate from the main delivery system; it has its own NO generator and gas flow delivery system. Backup NO flow can be delivered to one of two different locations by using the System Selector switch located on the front panel of the LungFit PH system. When the Selector Switch is turned to “Bagging System” position, the backup NO module turns on and delivers 1 L/min of 220 ppm of NO through a separate internal NO2 filter to the Bagging System connector on the front panel of the LungFit PH system. The Bagging System connector has two tubing fittings: one for connecting to an air/oxygen source through oxygen tubing or equivalent to provide an external flow of air/oxygen and the other to connect to a manual resuscitator for manually ventilating a patient. The 1 L/min NO flow from the backup NO module is added to this air/oxygen flow which dilutes the NO concentration down to therapeutic levels. Final NO concentration will depend on the amount of external flow added; for example, a flow of 10 L/min will provide 20 ppm of NO to the patient.
Beyond Air, Inc.
90005
In Commercial Distribution

  • B882900051 ()
  • B882900050 ()
  • B882900052 ()


  • Nitric oxide delivery unit, system-based
Radiography 7000 M digital mobile is a new motorized mobile x-ray system that includes: 1. Base Unit ( Sedecal Mobile X-ray system - SM-IV, cleared under K232185 August 21, 2023) 2. SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories 3. Eleva WorkSpot In addition, the following accessories can be used together with the system - Raidography 7000 M: - Detector Holder f. Patient Bed - Grid Landsc. SkyPlateE Large - Grid Landscape SkyPlate Large - Grid Portr. SkyPlate E Large - Grid Portrait SkyPlate Large - Grid Portrait SkyPlate Small - Handle for Skyplate Large - Portable Panel Protector - Wireless Detect. Mobile Holder - Set of 50 WPD Hygienic Bags (large) - Set of 50 WPD Hygienic Bags (small)
Philips Medical Systems DMC GmbH
712010
In Commercial Distribution

  • 00884838115521 ()


  • Mobile basic diagnostic x-ray system, digital
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