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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An over the counter, hand held device, intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
HOME SKINOVATIONS LTD
Solio Alfa +
In Commercial Distribution

  • 07290017992006 ()
  • 17290017992003 ()
  • 27290017992000 ()
7290017992006

  • Medium-wave diathermy treatment system generator
An over the counter, hand held device, intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
HOME SKINOVATIONS LTD
Relief International
In Commercial Distribution

  • 07290016627138 ()
  • 27290016627132 ()
  • 17290016627135 ()
7290016627138

  • Medium-wave diathermy treatment system generator
An over the counter, hand held device, intended to emit energy in the visible, near IR, and RF spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
HOME SKINOVATIONS LTD
Relief / HeatLux Pro II
In Commercial Distribution

  • 17290015418901 ()
  • 07290015418904 ()
  • 27290015418908 ()
7290015418904

  • Medium-wave diathermy treatment system generator
Icoone Laser Body (also referred to as Icoone body laser) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Icoone Medical Laser (model ref 611BC14) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (10mW) The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
I-TECH INDUSTRIES SRL
Icoone laser body (also referred to as Icoone body laser)
In Commercial Distribution

  • 18057592610369 ()

  • Pressure: 20 KiloPascal
611BC14

  • Freestanding electric massager
Icoone Laser (also referred to as Icoone Beauty Laser) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Icoone Medical Laser (model ref 610BEC04) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (10mW) The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
I-TECH INDUSTRIES SRL
Icoone Laser (also referred to as Icoone beauty laser)
In Commercial Distribution

  • 18057592610307 ()

  • Pressure: 20 KiloPascal
610BC04

  • Freestanding electric massager
Icoone Medical Laser (also referred to as Icoone Lase med) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Icoone Medical Laser (model ref 650EC24) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (1W) Through the display, the light sources can be fully deactivated, or both activated, or only LED activated. The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
I-TECH INDUSTRIES SRL
ICOONE Laser Med (also called ICOONE MEDICAL LASER)
In Commercial Distribution

  • 18057592610277 ()

  • Pressure: 20 KiloPascal
650EC24

  • Freestanding electric massager
Icoone h (also referred to as Icoone LASER and icoone-h LASER) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Icoone h (also referred to as Icoone LASER and icoone-h LASER) model ref 601EC14 is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (1W) The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
I-TECH INDUSTRIES SRL
ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
In Commercial Distribution

  • 18057592610246 ()

  • Pressure: 20 KiloPascal
601EC14

  • Freestanding electric massager
ST Single Use Tip
VIORA LTD
AS47010
In Commercial Distribution

  • 07290016746440 ()
  • 07290016746433 ()
AS47010

  • Radio-frequency skin/body contouring system
BodyFX
INMODE M.D LTD
AS600874A
In Commercial Distribution

  • 07290016633085 ()
AS600874A

  • Radio-frequency skin surface treatment system
No Description
Therabody, Inc.
TheraFace Hot & Cold Rings White
In Commercial Distribution

  • 00810036056809 ()


  • Electric pad localized-body heating system
  • Hot/cold therapy pack, reusable
No Description
Therabody, Inc.
TheraFace Hot & Cold Rings Black
In Commercial Distribution

  • 00810036056762 ()


  • Electric pad localized-body heating system
  • Hot/cold therapy pack, reusable
No Description
Therabody, Inc.
RecoveryTherm Hot/Cold/Vibration Knee
In Commercial Distribution

  • 00810036059732 ()


  • Hand-held electric massager
  • Electric pad localized-body heating system
  • Hot/cold therapy pack, reusable
No Description
W.O.M. World of Medicine GmbH
Z0260
In Commercial Distribution

  • 04056702007379 ()
  • 04056702007386 ()


  • Endoscopic insufflation tubing set, single-use
No Description
W.O.M. World of Medicine GmbH
Z0260
In Commercial Distribution

  • 04056702002831 ()


  • Endoscopic insufflation tubing set, single-use
No Description
W.O.M. World of Medicine GmbH
INSFHTDTUB
In Commercial Distribution

  • 04056702008789 ()
  • 04056702008772 ()


  • Endoscopic insufflation tubing set, single-use
Cryo Module (Requires connnection to product code 5108 for operation)
SAKURA FINETEK U.S.A., INC.
5109
In Commercial Distribution

  • 04946433600515 ()
5109

  • Tissue embedding unit IVD
Embedding Module
SAKURA FINETEK U.S.A., INC.
5108
In Commercial Distribution

  • 04946433600508 ()
5108

  • Tissue embedding unit IVD
Plus Cryo Console
SAKURA FINETEK U.S.A., INC.
5250
In Commercial Distribution

  • 04946433600492 ()
5250

  • Tissue embedding unit IVD
Automated Embedder
SAKURA FINETEK U.S.A., INC.
7090
In Commercial Distribution

  • 04946433600362 ()
7090

  • Tissue embedding unit IVD
Bath System - Primo Sys23 HS P300 Disp Des
Arjohuntleigh AB
AP33311US0011
In Commercial Distribution

  • 05055982718295 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P300 Disp Des
Arjohuntleigh AB
AP33311US0010
In Commercial Distribution

  • 05055982718288 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Disp Des
Arjohuntleigh AB
AP33212US2011
In Commercial Distribution

  • 05055982718219 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Disp Des
Arjohuntleigh AB
AP33212US2010
In Commercial Distribution

  • 05055982718202 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Disp Des
Arjohuntleigh AB
AP33212US2001
In Commercial Distribution

  • 05055982718196 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Disp Des
Arjohuntleigh AB
AP33212US2000
In Commercial Distribution

  • 05055982718189 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Disp Des
Arjohuntleigh AB
AP33212US1011
In Commercial Distribution

  • 05055982718172 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Disp Des
Arjohuntleigh AB
AP33212US1010
In Commercial Distribution

  • 05055982718165 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Disp Des
Arjohuntleigh AB
AP33212US1001
In Commercial Distribution

  • 05055982718158 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Disp Des
Arjohuntleigh AB
AP33212US1000
In Commercial Distribution

  • 05055982718141 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Disp Des
Arjohuntleigh AB
AP33212US0011
In Commercial Distribution

  • 05055982718134 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Disp Des
Arjohuntleigh AB
AP33212US0010
In Commercial Distribution

  • 05055982718127 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Disp Des
Arjohuntleigh AB
AP33212US0001
In Commercial Distribution

  • 05055982718110 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Disp Des
Arjohuntleigh AB
AP33212US0000
In Commercial Distribution

  • 05055982718103 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Disp Des
Arjohuntleigh AB
AP33211US0010
In Commercial Distribution

  • 05055982718097 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Des
Arjohuntleigh AB
AP33202US2011
In Commercial Distribution

  • 05055982717960 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Des
Arjohuntleigh AB
AP33202US2010
In Commercial Distribution

  • 05055982717953 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Des
Arjohuntleigh AB
AP33202US2001
In Commercial Distribution

  • 05055982717946 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Des
Arjohuntleigh AB
AP33202US2000
In Commercial Distribution

  • 05055982717939 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Des
Arjohuntleigh AB
AP33202US1011
In Commercial Distribution

  • 05055982717922 ()


  • Hydrotherapy bath/tank
Bath System - Primo Sys23 HS P220 Des
Arjohuntleigh AB
AP33202US1010
In Commercial Distribution

  • 05055982717915 ()


  • Hydrotherapy bath/tank
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