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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InModeRF HP 17x22x46 black
INMODE M.D LTD
HP172296A
In Commercial Distribution

  • 07290019863298 ()
HP172296A

  • Radio-frequency fat liquefaction system
FaceTite 2-Pack black
INMODE M.D LTD
HP101396A
In Commercial Distribution

  • 07290019863281 ()
HP101396A

  • Radio-frequency fat liquefaction system
AccuTite HP 2 Pack black
INMODE M.D LTD
HP060999A
In Commercial Distribution

  • 07290019863274 ()
HP060999A

  • Radio-frequency fat liquefaction system
AccuTite
INMODE M.D LTD
HP060909A
In Commercial Distribution

  • 07290016633481 ()
HP060909A

  • Radio-frequency fat liquefaction system
ARRUGA EYE SPEC F/RT EYE 2.75 INCHES
SKLAR CORPORATION
65-1031
In Commercial Distribution

  • 10649111432217 ()


  • Eyelid speculum, reusable
ARRUGA EYE SPEC F/LF EYE 2.75 INCHES
SKLAR CORPORATION
65-1030
In Commercial Distribution

  • 10649111432200 ()


  • Eyelid speculum, reusable
The sustained acoustic medicine, (sam® X1) long-duration ultrasound device is used in the treatment of musculoskeletal injuries and pain relief. sam® X1 is the first wire-free option to deliver continuous wave, high-frequency sustained acoustic medicine (3MHz) into deep tissue resulting in improved circulation and nutrient transfer into the injured soft-tissue for multiple hours each day. This sam® mechanism of action improves and accelerates soft tissue healing for tendinopathies, meniscus injuries, osteoarthritis, joint injuries (knee, shoulder, elbow, wrist) and tissue compromised by repetitive and/or overuse injuries. For pain management secondary to injury, sam® X1 provides localized, non-systemic pain management and is an appropriate treatment alternative for prescribers seeking to avoid the systemic effects of NSAIDs and opiates. sam® X1 is FDA cleared and indicated for prescription home-use, and easily accommodates self-administered treatment by applying the treatment applicator with a hypoallergenic single use pre-filled coupling patch over the soft-tissue injury and activating the battery-operated power controller for autonomous therapeutic delivery.
ZETROZ SYSTEMS, LLC
SA551
In Commercial Distribution

  • 00857599005202 ()
SA551

  • Physical therapy ultrasound system
The sustained acoustic medicine, (sam® 2.0) long-duration ultrasound device is intended for the treatment of musculoskeletal injuries and pain relief. sam® 2.0 delivers continuous wave, high-frequency sustained acoustic medicine (3MHz) into deep tissue for up to 4 hours, resulting in improved circulation and nutrient transfer into the injured soft-tissue for multiple hours each day. This sam® mechanism of action improves and accelerates soft tissue healing for tendinopathies, meniscus injuries, osteoarthritis, joint injuries (knee, shoulder, elbow, wrist) and tissue compromised by repetitive and/or overuse injuries. For pain management secondary to injury, sam® 2.0 provides localized, non-systemic pain management and is an appropriate treatment alternative for prescribers seeking to avoid the systemic effects of NSAIDs and opiates. sam® 2.0 is FDA cleared and indicated for prescription home-use, and easily accommodates self-administered treatment by applying the treatment applicator with a hypoallergenic single use pre-filled coupling patch over the soft-tissue injury and activating the battery-operated power controller for autonomous therapeutic delivery.
ZETROZ SYSTEMS, LLC
SA271
In Commercial Distribution

  • 00857599005196 ()


  • Physical therapy ultrasound system
wearable therapeutic ultrasound
ZETROZ SYSTEMS, LLC
sam-12
In Commercial Distribution

  • 00857599005073 ()


  • Physical therapy ultrasound system
Hands-Free Autosound
COMPASS HEALTH BRANDS CORP.
410-200
Not in Commercial Distribution

  • 00853904006322 ()


  • Physical therapy ultrasound system
Therapy Hammer- 2/3 cm Dual ultrasound applicator
COMPASS HEALTH BRANDS CORP.
410-115
Not in Commercial Distribution

  • 00853904006285 ()


  • Physical therapy ultrasound system
Therasound EVO (120V)
COMPASS HEALTH BRANDS CORP.
410-020
Not in Commercial Distribution

  • 00853904006186 ()


  • Physical therapy ultrasound system
Therasound 3 Standard (120V)
COMPASS HEALTH BRANDS CORP.
410-026
Not in Commercial Distribution

  • 00853904006179 ()


  • Physical therapy ultrasound system
A handheld ultrasound device for the treatment of pain and discomfort in the joints and muscles. Product includes ultrasound device and power supply.
AXIOSONIC, LLC
64-405-0004
In Commercial Distribution

  • 00861681000327 ()


  • Physical therapy ultrasound system
A handheld ultrasound device for the treatment of pain and discomfort in the joints and muscles. Product includes ultrasound device and power supply.
AXIOSONIC, LLC
64-405-0005
In Commercial Distribution

  • 00861681000310 ()


  • Physical therapy ultrasound system
A handheld ultrasound device for the treatment of pain and discomfort in the joints and muscles. Product includes ultrasound device and power supply.
AXIOSONIC, LLC
64-405-0003
In Commercial Distribution

  • 00861681000303 ()


  • Physical therapy ultrasound system
Winner EVO-CM2, 220v
COMPASS HEALTH BRANDS CORP.
210-010-220
In Commercial Distribution

  • 00852515007735 ()


  • Physical therapy ultrasound system
THERASOUND EVO 220, THERAPY HAMMER, LASER MODULE, LEAD CORDS, 5CM GELSHOTS & ADAPTORS
COMPASS HEALTH BRANDS CORP.
410-020-220
Not in Commercial Distribution

  • 00852515007162 ()


  • Physical therapy ultrasound system
AUTOSOUND 9.6
COMPASS HEALTH BRANDS CORP.
400-021
In Commercial Distribution

  • 00852515007049 ()


  • Physical therapy ultrasound system
Welcome to the Omnisound® 3000 Pro, the system that redefines therapeutic ultrasound. While conceiving and designing the Omnisound® 3000 Pro, ACP set out to overcome the limitations of ordinary ultrasound devices. Here are just a few of the functions we developed that make the Omnisound® 3000 Pro truly the future of ultrasound therapy: • Controlled Depth of Penetration - The Omnisound® 3000 Pro enables you to treat soft tissue injuries, superficially with 3 MHz and instantly at the push of a button, treat deeper injuries with 1 MHz - without switching transducers. • Two Transducer Sizes - Our 2cm2 and 5cm2 heads offer optimum flexibility in treatment and are automatically enabled as you change from one to the other. • Combination Therapy - Interconnect port allows combination therapy with the Omnistim® family of electrostimulators. • Excellent BNR and ERA - Our superior BNR and ERA makes for highly uniform and comfortable applications.
ACCELERATED CARE PLUS CORP
1203000E
In Commercial Distribution

  • 10858703006006 ()
  • 00858703006009 ()


  • Physical therapy ultrasound system
No Description
HILL LABORATORIES CO.
HF54, Horizon
In Commercial Distribution

  • 00860001452532 ()


  • Physical therapy ultrasound system
Therasound 3 Standard (220V)
COMPASS HEALTH BRANDS CORP.
410-029
Not in Commercial Distribution

  • 00850958007480 ()


  • Physical therapy ultrasound system
Therasound EVO (220V)
COMPASS HEALTH BRANDS CORP.
410-028
Not in Commercial Distribution

  • 00850958007107 ()


  • Physical therapy ultrasound system
Therasound 3.5P
COMPASS HEALTH BRANDS CORP.
400-020
Not in Commercial Distribution

  • 00850958007084 ()


  • Physical therapy ultrasound system
VIBRALUNG® HHT Hanger
WESTMED, INC.
9641
In Commercial Distribution

  • 10709078002417 ()
  • 00709078002410 ()


  • Electroacoustical airway secretion-clearing system
Demo User Kit with Travel Bag, VIBRALUNG®
WESTMED, INC.
9501D
In Commercial Distribution

  • 00709078002403 ()


  • Electroacoustical airway secretion-clearing system
Demo Treatment Control Unit Assembly, VIBRALUNG® Acoustical
WESTMED, INC.
9500D
In Commercial Distribution

  • 00709078002397 ()


  • Electroacoustical airway secretion-clearing system
No Description
WESTMED, INC.
9643
In Commercial Distribution

  • 10709078001540 ()
  • 00709078001543 ()


  • Electroacoustical airway secretion-clearing system
No Description
WESTMED, INC.
9630
In Commercial Distribution

  • 00709078001536 ()
  • 10709078001533 ()


  • Electroacoustical airway secretion-clearing system
No Description
WESTMED, INC.
9642
In Commercial Distribution

  • 10709078001526 ()
  • 00709078001529 ()


  • Electroacoustical airway secretion-clearing system
No Description
WESTMED, INC.
9646
In Commercial Distribution

  • 00709078001512 ()
  • 10709078001519 ()


  • Electroacoustical airway secretion-clearing system
No Description
WESTMED, INC.
9640
In Commercial Distribution

  • 00709078001376 ()
  • 10709078001373 ()


  • Electroacoustical airway secretion-clearing system
1 each: Standard Y Adapter, Aerosol Y-Adapter, Hand-held Transducer (HHT) assembly with screw-on Cone pre-attached, and disposable ear plugs.
WESTMED, INC.
9600
In Commercial Distribution

  • 00709078001369 ()
  • 10709078001366 ()


  • Electroacoustical airway secretion-clearing system
No Description
WESTMED, INC.
9501
In Commercial Distribution

  • 00709078001345 ()
  • 10709078001342 ()


  • Electroacoustical airway secretion-clearing system
No Description
WESTMED, INC.
9500
In Commercial Distribution

  • 00709078001338 ()
  • 10709078001335 ()


  • Electroacoustical airway secretion-clearing system
THERASOUND Evo Device with hammer, electrodes, & gel
COMPASS HEALTH BRANDS CORP.
410-020-HMR
In Commercial Distribution

  • 00092237902530 ()


  • Physical therapy ultrasound system
Winner Evo CM2 Device W/ HAMMER, electrodes, gel and lead wires
COMPASS HEALTH BRANDS CORP.
410-010-HMR
In Commercial Distribution

  • 00092237902523 ()


  • Physical therapy ultrasound system
Therasound 3.5P - Device
COMPASS HEALTH BRANDS CORP.
400-020
Not in Commercial Distribution

  • 00092237901731 ()


  • Physical therapy ultrasound system
Therasound 3 Standard Device Only (120V)
COMPASS HEALTH BRANDS CORP.
410-026
Not in Commercial Distribution

  • 00092237901236 ()
  • 01092237901235 ()


  • Physical therapy ultrasound system
Therasound EVO Device Only (220V)
COMPASS HEALTH BRANDS CORP.
410-028
In Commercial Distribution

  • 00092237901229 ()


  • Physical therapy ultrasound system
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