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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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
THERASOUND Evo Device Only - 120V
COMPASS HEALTH BRANDS CORP.
410-020
In Commercial Distribution

  • 00092237901212 ()


  • Physical therapy ultrasound system
Ultra Cure Pro PLUS
COMPASS HEALTH BRANDS CORP.
DU3038
In Commercial Distribution

  • 80092237618864 ()
  • 00092237618868 ()


  • Physical therapy ultrasound system
DS SoundCare Plus - Prof.
COMPASS HEALTH BRANDS CORP.
DS-ULTRSND
In Commercial Distribution

  • 80092237618727 ()
  • 00092237618721 ()


  • Physical therapy ultrasound system
SoundCare Plus - Wand, 5 cm
COMPASS HEALTH BRANDS CORP.
DQ9275W5
In Commercial Distribution

  • 00092237618226 ()


  • Physical therapy ultrasound system
SoundCare Plus - Wand, 1 cm
COMPASS HEALTH BRANDS CORP.
DQ9275W1
In Commercial Distribution

  • 00092237618219 ()


  • Physical therapy ultrasound system
US 1000 3rd - Portable
COMPASS HEALTH BRANDS CORP.
DU1025
In Commercial Distribution

  • 80092237616808 ()
  • 00092237616802 ()


  • Physical therapy ultrasound system
SoundCare Plus - Professional
COMPASS HEALTH BRANDS CORP.
DQ9275
In Commercial Distribution

  • 80092237616747 ()
  • 00092237616741 ()


  • Physical therapy ultrasound system
5cm Sound Head - 2nd Gen
COMPASS HEALTH BRANDS CORP.
DQ8000W5
Not in Commercial Distribution

  • 80092237616440 ()
  • 00092237616444 ()


  • Physical therapy ultrasound system
1cm Sound Head - 2nd Gen
COMPASS HEALTH BRANDS CORP.
DQ8000W1
Not in Commercial Distribution

  • 80092237616433 ()
  • 00092237616437 ()


  • Physical therapy ultrasound system
UltraTENS II - Ultrasound and
COMPASS HEALTH BRANDS CORP.
DU6012
In Commercial Distribution

  • 80092237611636 ()
  • 00092237611630 ()


  • Physical therapy ultrasound system
LG Pro Series 2nd Edition
COMPASS HEALTH BRANDS CORP.
DU3037
In Commercial Distribution

  • 80092237611568 ()
  • 00092237611562 ()


  • Physical therapy ultrasound system
US Pro 2000 2nd Edition
COMPASS HEALTH BRANDS CORP.
DU3035
In Commercial Distribution

  • 80092237611544 ()
  • 00092237611548 ()


  • Physical therapy ultrasound system
INTELECT LEGEND ULTRASOUND US STD
DJO, LLC
INT001
In Commercial Distribution

  • 00888912043359 ()


  • Physical therapy ultrasound system
INTELECT XT 4CH,COMBO,US STD 5CM APPL W/CART
DJO, LLC
2795
In Commercial Distribution

  • 00888912022095 ()


  • Physical therapy ultrasound system
INTELECT LEGEND XT COMBO US STD W/CART
DJO, LLC
2791
In Commercial Distribution

  • 00888912022057 ()


  • Physical therapy ultrasound system
INTELECT TRANSPORT US STD
DJO, LLC
2782
In Commercial Distribution

  • 00888912022019 ()


  • Physical therapy ultrasound system
INTELECT TRANSPORT COMBO PKG US STD
DJO, LLC
2738
In Commercial Distribution

  • 00888912021883 ()


  • Physical therapy ultrasound system
KIT VECTRA GEN 2C STIM W/O EM FG1
DJO, LLC
2875
In Commercial Distribution

  • 00888912297028 ()


  • Physical therapy ultrasound system
VECTRA GEN 2C COMBO W/O EMG PK US STD
DJO, LLC
2872
In Commercial Distribution

  • 00888912296854 ()


  • Physical therapy ultrasound system
SENIOR SOLUTIONS 4CH STIM PKG US STD
DJO, LLC
2866
In Commercial Distribution

  • 00888912296793 ()


  • Physical therapy ultrasound system
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