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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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MEDI - 00636257111567

20-30 SHRINKER BK 12" SHORT BEIGE SZ 1
MEDI MANUFACTURING, INC.
BK1S0N1
In Commercial Distribution

  • 00636257111567 ()


  • Limb-worn device hygienic cover

MEDI - 00636257111499

20-30 SHRINKER BK 15" MED BEIGE SZ 1
MEDI MANUFACTURING, INC.
BK1M0N1
In Commercial Distribution

  • 00636257111499 ()


  • Limb-worn device hygienic cover

MEDI - 00636257111475

20-30 SHRINKER BK 18" LONG BEIGE SZ 6
MEDI MANUFACTURING, INC.
BK1L0N6
In Commercial Distribution

  • 00636257111475 ()


  • Limb-worn device hygienic cover

MEDI - 00636257111451

20-30 SHRINKER BK 18" LONG BEIGE SZ 4
MEDI MANUFACTURING, INC.
BK1L0N4
In Commercial Distribution

  • 00636257111451 ()


  • Limb-worn device hygienic cover

WalkAnalyst Software Kit - 00858184006130

Software used by the clinician to interface with the WalkAide unit. This allows data collection, analysis and parameter modification in order to correctly time the applied stimulation to the user.
INNOVATIVE NEUROTRONICS, INC.
20-0603
In Commercial Distribution

  • 00858184006130 ()


  • Gait-enhancement electrical stimulation system, external

WalkLink System ((Clinician Kit) - 00858184006062

Provides a wireless connection between the WalkAide and a computer, and also allows manual stimulation during walking trials via the Hand Switch.
INNOVATIVE NEUROTRONICS, INC.
20-0300
In Commercial Distribution

  • 00858184006062 ()


  • Gait-enhancement electrical stimulation system, external

WalkLink Unit - 00858184006055

Provides a wireless connection between the WalkAide and a computer, and also allows manual stimulation during walking trials via the Hand Switch.
INNOVATIVE NEUROTRONICS, INC.
20-0310
In Commercial Distribution

  • 00858184006055 ()


  • Gait-enhancement electrical stimulation system, external

WalkAide Kit for Demo Use - 00858184006048

The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates a foot lift at the correct time during walking. A foot drop occurs when a person connot lift the foot on their own. This results in the foot slapping on the floor or the toes dragging during walking. The WalkAide stimulates a nerve as it passes below the knee and activates the muscles that raise the foot.The WalkAide Patient Kit includes a WalkAide Control Unit, a WalkAide cuff, and an electrode lead cable. A foot sensor is an optional item
INNOVATIVE NEUROTRONICS, INC.
20-1002
In Commercial Distribution

  • 00858184006048 ()


  • Gait-enhancement electrical stimulation system, external

WalkAide Kit for Japan - 00858184006031

The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates a foot lift at the correct time during walking. A foot drop occurs when a person connot lift the foot on their own. This results in the foot slapping on the floor or the toes dragging during walking. The WalkAide stimulates a nerve as it passes below the knee and activates the muscles that raise the foot.The WalkAide Patient Kit includes a WalkAide Control Unit, a WalkAide cuff, and an electrode lead cable. A foot sensor is an optional item.
INNOVATIVE NEUROTRONICS, INC.
21-1000
In Commercial Distribution

  • 00858184006031 ()


  • Gait-enhancement electrical stimulation system, external

WalkAide Kit - 00858184006017

The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates a foot lift at the correct time during walking. A foot drop occurs when a person connot lift the foot on their own. This results in the foot slapping on the floor or the toes dragging during walking. The WalkAide stimulates a nerve as it passes below the knee and activates the muscles that raise the foot.The WalkAide Patient Kit includes a WalkAide Control Unit, a WalkAide cuff, and an electrode lead cable. A foot sensor is an optional item.
INNOVATIVE NEUROTRONICS, INC.
20-1000
In Commercial Distribution

  • 00858184006017 ()


  • Gait-enhancement electrical stimulation system, external

WalkAide Unit - 00858184006000

The WalkAide is a battery-operated, single channel electrical stimulator that is used to improve walking ability. It stimulates a foot lift at the correct time during walking. A foot drop occurs when a person connot lift the foot on their own. This results in the foot slapping on the floor or the toes dragging during walking. The WalkAide stimulates a nerve as it passes below the knee and activates the muscles that raise the foot.
INNOVATIVE NEUROTRONICS, INC.
20-0100
In Commercial Distribution

  • 00858184006000 ()


  • Gait-enhancement electrical stimulation system, external

ATLAS Stim Headbox - NK - 00867718000285

ATLAS Stim Headbox with Nihon Kohden passive side panel.
NEURALYNX, INC.
NK
In Commercial Distribution

  • 00867718000285 ()
31-0601-0077

  • Somatosensory electrical stimulation system

NA - 10886982199461

WRIST COVER
Synthes GmbH
394.052
In Commercial Distribution

  • H6793940520 ()
  • 10886982199461 ()
394052

  • Limb-worn device hygienic cover

RehaStim 2 - 04260397620342

External Functional Neuromuscular Stimulator (8 channels), designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician.
HASOMED GmbH
FES01090
In Commercial Distribution

  • 04260397620342 ()
FES01090

  • Gait-enhancement electrical stimulation system, external

RehaStim 2 - 04260397620670

External Functional Neuromuscular Stimulator (8 channels), designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician. - manufactured for use in system
HASOMED GmbH
FES01050
In Commercial Distribution

  • 04260397620670 ()
FES01050

  • Gait-enhancement electrical stimulation system, external

RehaStim2 - 04260397620410

External Functional Neuromuscular Stimulator (8 channels), designed for use as stand-alone device as well as in combination with exercise equipment for walking and cycling applications, that has been validated for compatibility by HASOMED GmbH and should be used under the supervision of a clinician. - manufactured for use in system
HASOMED GmbH
FES01092
In Commercial Distribution

  • 04260397620410 ()
FES01092

  • Gait-enhancement electrical stimulation system, external

Micromed - 08033928120828

The SD LTM STIM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG).
MICROMED SPA
SD LTM STIM
In Commercial Distribution

  • 08033928120828 ()


  • Somatosensory electrical stimulation system

L360 Thigh System - 00815962020399

L360 Thigh System Kit, Right
BIONESS INC.
L4T-6000
In Commercial Distribution

  • 00815962020399 ()


  • Gait-enhancement electrical stimulation system, external

L360 Thigh System - 00815962020382

L360 Thigh System Kit, Left
BIONESS INC.
L4T-6001
In Commercial Distribution

  • 00815962020382 ()


  • Gait-enhancement electrical stimulation system, external

L100 Go System - 00815962020344

L100 Go System, Left
BIONESS INC.
LG1-5X00
In Commercial Distribution

  • 00815962020344 ()


  • Gait-enhancement electrical stimulation system, external
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