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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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No Description
NATURAL BREAST K.K.
1
In Commercial Distribution

  • 04580028445954 ()


  • External breast prosthesis
  • Nipple prosthesis, external
No Description
NATURAL BREAST K.K.
1
In Commercial Distribution

  • 04580028445947 ()


  • External breast prosthesis
  • Nipple prosthesis, external
No Description
NATURAL BREAST K.K.
1
In Commercial Distribution

  • 04580028445930 ()


  • External breast prosthesis
  • Nipple prosthesis, external
No Description
NATURAL BREAST K.K.
1
In Commercial Distribution

  • 04580028445909 ()


  • External breast prosthesis
  • Nipple prosthesis, external
No Description
NATURAL BREAST K.K.
1
In Commercial Distribution

  • 04580028445893 ()


  • External breast prosthesis
  • Nipple prosthesis, external
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
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
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
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
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
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
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
Control software for the ATLAS Stim Headbox.
NEURALYNX, INC.
1.5.1
Not in Commercial Distribution

  • 00850011306703 ()
36-0301-0006

  • Somatosensory electrical stimulation system
ATLAS Stim Headbox with High Density side panel.
NEURALYNX, INC.
High Density
In Commercial Distribution

  • 00850011306345 ()
31-0601-0132

  • Somatosensory electrical stimulation system
ATLAS Stim Headbox with Touchproof side panel.
NEURALYNX, INC.
Touchproof
In Commercial Distribution

  • 00850011306338 ()
31-0601-0089

  • Somatosensory electrical stimulation system
ATLAS Stim Headbox with Nihon Kohden passive side panel.
NEURALYNX, INC.
NK
In Commercial Distribution

  • 00867718000285 ()
31-0601-0077

  • Somatosensory electrical stimulation system
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
Cionic Neural Sleeve NS-100
Cionic, Inc.
NS-100
In Commercial Distribution

  • G345NS1000 ()
NS100

  • Gait-enhancement electrical stimulation system, external
CIONIC Android Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000040 ()
62000004

  • Gait-enhancement electrical stimulation system, external
CIONIC iOS Gateway App
Cionic, Inc.
10
In Commercial Distribution

  • G345620000030 ()
62000003

  • Gait-enhancement electrical stimulation system, external
Cionic Neural Sleeve NS-100 - Sleeve
Cionic, Inc.
SL-100
In Commercial Distribution

  • G345SL1000 ()
SL100

  • Gait-enhancement electrical stimulation system, external
Cionic Neural Sleeve NS-100 - Control Unit
Cionic, Inc.
DC-100
In Commercial Distribution

  • G345DC1000 ()
DC100

  • Gait-enhancement electrical stimulation system, external
Single channel, transcutaneous neuromuscular stimulator for relief of dropped foot. Also cleared for gait re-education and similar applications plus physical therapy uses.
ODSTOCK MEDICAL LIMITED
1.1
In Commercial Distribution

  • 05060195470441 ()
00-001-0019

  • Gait-enhancement electrical stimulation system, external
!30-40 SHRINKER AK 12" LONG BEIGE SZ 4
MEDI MANUFACTURING, INC.
KAK2L0W4
In Commercial Distribution

  • 00636257014561 ()


  • Limb-worn device hygienic cover
!30-40 SHRINKER AK 12" LONG BEIGE SZ 3
MEDI MANUFACTURING, INC.
KAK2L0W3
In Commercial Distribution

  • 00636257014554 ()


  • Limb-worn device hygienic cover
!30-40 SHRINKER AK 12" LONG BEIGE SZ 2
MEDI MANUFACTURING, INC.
KAK2L0W2
In Commercial Distribution

  • 00636257014547 ()


  • Limb-worn device hygienic cover
!30-40 SHRINKER AK 12" LONG BEIGE SZ 1
MEDI MANUFACTURING, INC.
KAK2L0W1
In Commercial Distribution

  • 00636257014530 ()


  • Limb-worn device hygienic cover
!20-30 SHRINKER AK 14" XLONG BLACK SZ 6
MEDI MANUFACTURING, INC.
KAK1X5W6
In Commercial Distribution

  • 00636257014523 ()


  • Limb-worn device hygienic cover
!20-30 SHRINKER AK 14" XLONG BLACK SZ 5
MEDI MANUFACTURING, INC.
KAK1X5W5
In Commercial Distribution

  • 00636257014516 ()


  • Limb-worn device hygienic cover
!20-30 SHRINKER AK 14" XLONG BLACK SZ 4
MEDI MANUFACTURING, INC.
KAK1X5W4
In Commercial Distribution

  • 00636257014509 ()


  • Limb-worn device hygienic cover
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