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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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K Myo - 03770011995875

K Myo is a biofeedback device for training muscle groups by means of electromyography
KINVENT BIOMECANIQUE
K Myo Black V3
In Commercial Distribution

  • 03770011995875 ()


  • Electromyograph

K Myo - 03770011995707

K Myo is a biofeedback device for training muscle groups by means of electromyography
KINVENT BIOMECANIQUE
K Myo V3
In Commercial Distribution

  • 03770011995707 ()


  • Electromyograph

KForce Deltas XL - 03770011995608

K Deltas are two large independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength
KINVENT BIOMECANIQUE
K Deltas XL V3
In Commercial Distribution

  • 03770011995608 ()


  • Biomechanical function analysis system, force-testing, portable

KForce Sens - 03770011995462

K Move is an inertial sensor to measure the range of motion and to compare the symmetry between the injured limb’s amplitude and the healthy limb.
KINVENT BIOMECANIQUE
K Move V3
In Commercial Distribution

  • 03770011995462 ()


  • Electronic goniometer/kinesiology sensor

KForce Bubble - 03770011995455

K Bubble is a pneumatic sensor allowing to work your strength with convenient inflatable tools.
KINVENT BIOMECANIQUE
K Bubble V3
In Commercial Distribution

  • 03770011995455 ()


  • Back/leg/chest dynamometer, electronic

KForce Grip - 03770011995431

K Grip is used for the evaluation of hand grip strength. You can assess isometric strength by the way of the peak force as well as of the average force. The K Grip dynamometer allows to quantitatively measure the grip weakness caused by injury compared to the strength of the healthy hand."
KINVENT BIOMECANIQUE
K Grip V3
In Commercial Distribution

  • 03770011995431 ()


  • Hand dynamometer/pinchmeter, electronic

KForce Link - 03770011995424

K Pull is a traction dynamometer for the measurement of isometric strength and biofeedback training. K Pull enables independent measurements. It can be fixed on a physiotherapists table, on the espalier or on pulley machines.
KINVENT BIOMECANIQUE
K Pull V3
In Commercial Distribution

  • 03770011995424 ()


  • Back/leg/chest dynamometer, electronic

KForce Deltas - 03770011995417

K Deltas are two large independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength
KINVENT BIOMECANIQUE
K Deltas V3
In Commercial Distribution

  • 03770011995417 ()


  • Biomechanical function analysis system, force-testing, portable

KForce Plates - 03770011995387

K Plates are two independent force platforms for rehabilitating balance and assessing lower limb muscular symmetry and strength
KINVENT BIOMECANIQUE
K Force Plates V3
In Commercial Distribution

  • 03770011995387 ()


  • Biomechanical function analysis system, force-testing, portable

KForce Muscle Controller - 03770011995370

K Push is a hand held dynamometer used for the evaluation of muscles strength. You can assess isometric strength by the way of the peak force as well as of the average force for a specific muscle or muscle groups. The K Push allows to quantitatively measure the muscle strength and the deficit percentage caused by injury compared to the strength of the healthy side.
KINVENT BIOMECANIQUE
K Push V3
In Commercial Distribution

  • 03770011995370 ()


  • Back/leg/chest dynamometer, electronic

Eccentron - 10850390007816

A recumbent, closed-chain exercise device that provides eccentric (negative) resistance to lower extremity motion. It also measures strength and dynamic workload through its computer interface.
BTE TECHNOLOGIES, INC.
LE1
In Commercial Distribution

  • 10850390007816 ()


  • Bicycle ergometer

MCU Multi-Cervical Unit - 10850390007427

A rehabilitation device for neck strengthening exercises, as well as measurement of cervical spine range of motion and strength. Neck musculoskeletal measurements can be taken for flexion, extension, lateral flexion, rotation, and for combined planes.
BTE TECHNOLOGIES, INC.
MCU 2
In Commercial Distribution

  • 10850390007427 ()


  • Neck mechanical weight exerciser

Prism - 10850390007380

A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
Prism1
In Commercial Distribution

  • 10850390007380 ()


  • Biomechanical function analysis system, force-testing, stationary

Evaluator - 10850390007373

A portable measurement system for quantifying musculoskeletal strength and range of motion. Various EV versions are available that are different configurations of the same medical device model.
BTE TECHNOLOGIES, INC.
Evaluator EV
Not in Commercial Distribution

  • 10850390007373 ()


  • Biomechanical function analysis system, force-testing, portable

EVJ - 10850390007366

A portable measurement system for quantifying musculoskeletal strength and range of motion.
BTE TECHNOLOGIES, INC.
Evaluator EVJ
In Commercial Distribution

  • 10850390007366 ()


  • Biomechanical function analysis system, force-testing, portable

Provider Test Kit (PTK) - 10850390007359

A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
1
In Commercial Distribution

  • 10850390007359 ()


  • Biomechanical function analysis system, force-testing, stationary

PrimusRS - 10850390007243

A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
PrimusRS
In Commercial Distribution

  • 10850390007243 ()


  • Biomechanical function analysis system, force-testing, stationary

Primus - 10850390007236

A very versatile rehabilitation device for upper extremity and lower extremity strength testing and exercise. The dynamometer offers isometric, isotonic, isokinetic, eccentric, concentric, and continuous passive motion modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
Primus+
Not in Commercial Distribution

  • 10850390007236 ()


  • Biomechanical function analysis system, force-testing, stationary

AQUAbase® - 04046955725175

AQUAbase nX 750HT (60Hz/208-220V)
B.Braun Avitum AG
LA1101376
In Commercial Distribution

  • 04046955725175 ()
LA1101376

  • Reverse-osmosis water purification system

AQUAbase® - 04046955725168

AQUAbase® nX HT 500 Reverse Osmosis System
B.Braun Avitum AG
LA1101351
In Commercial Distribution

  • 04046955725168 ()
LA1101351

  • Reverse-osmosis water purification system

AQUAbase® - 04046955725151

AQUAbase® nX HT 250 Reverse Osmosis System
B.Braun Avitum AG
LA1101326
In Commercial Distribution

  • 04046955725151 ()
LA1101326

  • Reverse-osmosis water purification system

ELEXIR - 08800051500199

No Description
Nu Eyne Co., Ltd.
ALLIVE2
In Commercial Distribution

  • 08800051500199 ()


  • Craniofacial analgesia electrical stimulator

Powered breast pump - 08800051100566

2pumps+Dock
IMANI
imani i2Plus
In Commercial Distribution

  • 08800051100566 ()


  • Breast pump, electric

Powered breast pump - 08800051100559

2pumps+iBox
IMANI
imani i2Plus
In Commercial Distribution

  • 08800051100559 ()


  • Breast pump, electric

Powered breast pump - 08800051100542

2pumps
IMANI
imani i2Plus
In Commercial Distribution

  • 08800051100542 ()


  • Breast pump, electric

Powered breast pump - 08800051100504

2pumps with iBox
IMANI
imani i2Plus
Not in Commercial Distribution

  • 08800051100504 ()


  • Breast pump, electric

Powered breast pump - 08800051100498

21mm insert 25mm funnel
IMANI
imani i2
In Commercial Distribution

  • 08800051100498 ()
  • 08800051100108 ()
  • 18800051100495 ()


  • Breast pump, electric

Powered breast pump - 08800051100474

2pumps+Dock
IMANI
imani i2Plus
Not in Commercial Distribution

  • 08800051100474 ()


  • Breast pump, electric

Powered breast pump - 08800051100290

No Description
IMANI
imani i2Plus
In Commercial Distribution

  • 08800051100290 ()


  • Breast pump, electric

Powered breast pump - 08800051100115

No Description
IMANI
imani i1Plus
Not in Commercial Distribution

  • 08800051100115 ()


  • Breast pump, electric

Powered breast pump - 08800051100108

No Description
IMANI
imani i2
Not in Commercial Distribution

  • 08800051100108 ()


  • Breast pump, electric

Powered breast pump - 08800051100047

No Description
IMANI
imani i1
In Commercial Distribution

  • 08800051100047 ()
  • 18800051100044 ()


  • Breast pump, electric

SISLOY - 10866057000311

An over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
HOME SKINOVATIONS LTD
Supreme
In Commercial Distribution

  • 00866057000314 ()
  • 20866057000318 ()
  • 10866057000311 ()
866057000314

  • Cosmetic red-light phototherapy system, home-use

HandyRay-Lite - 08800031600086

No Description
Lameditech Co., Ltd.
LMT-1000
In Commercial Distribution

  • 08800031600086 ()


  • Manual blood lancing device, reusable

HandyRay-Pro - 08800031600062

No Description
Lameditech Co., Ltd.
LMT-5000
In Commercial Distribution

  • 08800031600062 ()
  • 18800031600069 ()
  • 28800031600066 ()
  • 38800031600063 ()
  • 48800031600060 ()


  • Manual blood lancing device, reusable

HandyRay - 08800031600017

No Description
Lameditech Co., Ltd.
LMT-3000
In Commercial Distribution

  • 08800031600017 ()
  • 08800031600055 ()
  • 08800031600048 ()
  • 08800031600031 ()
  • 08800031600024 ()


  • Manual blood lancing device, reusable

Digital Refractor HDR-7000P - 08800019600817

Digital Refractor system is a computerized auto refractor used for subjective refraction by regarding the patient’s accommodation power and facilities.
Huvitz Co., Ltd.
HDR-7000P
In Commercial Distribution

  • 08800019600817 ()
HDR-7000P

  • Phoropter

Slit Lamp HS-5000 - 08800019600114

-. Magnfication : 3 position rotation drum -. Lamp : LED Lamp ( 10V 4.4W)
Huvitz Co., Ltd.
HS-5000
In Commercial Distribution

  • 08800019600114 ()
HS-5000

  • Ophthalmic examination slit lamp

Slit Lamp HS-5000 - 08800019600107

" -. Magnfication : 3 position rotation drum -. Lamp : Halogen Bulb ( 12V 30W )"
Huvitz Co., Ltd.
HS-5000
In Commercial Distribution

  • 08800019600107 ()
HS-5000

  • Ophthalmic examination slit lamp

Slit Lamp HS-7000 - 08800019600060

" -. Magnfication : 5 position rotation drum -. Lamp : LED Lamp ( 10V 4.4W)"
Huvitz Co., Ltd.
HS-7000
In Commercial Distribution

  • 08800019600060 ()
HS-7000

  • Ophthalmic examination slit lamp
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