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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Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
EKSO BIONICS, INC.
501-100-000
In Commercial Distribution

  • M704501100000 ()


  • Programmable ambulation exoskeleton, clinical
Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.
EKSO BIONICS, INC.
501-110-001
In Commercial Distribution

  • M704501110001 ()


  • Programmable ambulation exoskeleton, clinical
The Atalante X by Wandercraft is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self-balancing and includes dynamic-walking control. Dynamic walking allows the Atalante X to consume significantly less power and have a more natural gait. The Atalante X is a tool for physical therapy. It is meant to be highly adjustable and be applicable for various stages of physical rehabilitation, re-mobilization and exercises.
WANDERCRAFT
ATA-002-EN US
In Commercial Distribution

  • 03665965000129 ()


  • Programmable ambulation exoskeleton, clinical
Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical
Trexo Robotics XL Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321072 ()

  • XL
A001BPX

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Large Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321065 ()

  • Large
A001BPR

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Medium Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321058 ()

  • Medium
A001BPR

  • Programmable ambulation exoskeleton, clinical
Trexo Robotics Small Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321041 ()

  • Small
A001BPR

  • Programmable ambulation exoskeleton, clinical
EKSO BIONICS SYSTEM, Ekso NR
EKSO BIONICS, INC.
EKSONR
In Commercial Distribution

  • B168EKSONR0 ()
EKSONR

  • Programmable ambulation exoskeleton, clinical
EKSO BIONICS SYSTEM, Ekso GT
EKSO BIONICS, INC.
EKSOGT
In Commercial Distribution

  • B168EKSOGT0 ()
EKSOGT

  • Programmable ambulation exoskeleton, clinical
The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
EKSO BIONICS, INC.
GT
In Commercial Distribution

  • B1431200000 ()


  • Programmable ambulation exoskeleton, clinical
The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
REWALK ROBOTICS LTD
50-40-0001
In Commercial Distribution

  • 00860001744507 ()


  • Programmable ambulation exoskeleton, clinical
Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical
No Description
HOCOMA AG
Pro 6.3 PE Motivation
In Commercial Distribution

  • 07640174660483 ()
63060

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 AD Motivation
In Commercial Distribution

  • 07640174660476 ()
63059

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 Kombi Motivation
In Commercial Distribution

  • 07640174660469 ()
63058

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 PE
In Commercial Distribution

  • 07640174660452 ()
63057

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 AD
In Commercial Distribution

  • 07640174660445 ()
63056

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 FD PE
In Commercial Distribution

  • 07640174660421 ()
63054

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 FD Kombi
In Commercial Distribution

  • 07640174660407 ()
63052

  • Treadmill/elliptical gait rehabilitation system
microTargeting(TM) electrode, back loaded, non sterile, specify impedance, platinum/iridium, glass insulated
FHC, INC.
MTBPXN(EN3)-00307
In Commercial Distribution

  • 10873263003074 ()
  • 00873263003077 ()

  • Length: 40 Millimeter
  • Length: 280 Millimeter
  • Outer Diameter: 0.63 Millimeter
MTBPXN(EN3)

  • Depth electrode
microTargeting(TM) Electrode, back loaded, non sterile, platinum/iridium, glass insulated
FHC, INC.
MTBPBN(KB1)-00302
In Commercial Distribution

  • 10873263003029 ()
  • 00873263003022 ()

  • Length: 30 Millimeter
  • Length: 305 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.63 Millimeter
MTBPBN(KB1)

  • Depth electrode
microTargeting(TM) Electrode, back loaded, non sterile, Platinum/Iridium, glass insulated
FHC, INC.
MTBPBN(EN2)-00297
In Commercial Distribution

  • 10873263002978 ()
  • 00873263002971 ()

  • Outer Diameter: 0.63 Millimeter
  • Length: 50 Millimeter
  • Length: 300 Millimeter
  • Impedance: Megaohms
MTBPBN(EN2)

  • Depth electrode
microTargeting(TM) Electrode, Back loaded, Platinum/Iridium with Glass Insulation
FHC, INC.
MTBPBN(AZ1)-00291
In Commercial Distribution

  • 10873263002916 ()
  • 00873263002919 ()

  • Outer Diameter: 0.63 Millimeter
  • Length: 35 Millimeter
  • Impedance: Megaohms
  • Length: 260 Millimeter
MTBPBN(AZ1)

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, D.ZAP(Z), Platform
FHC, INC.
44935Z-00256
In Commercial Distribution

  • 10873263002565 ()
  • 00873263002568 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 220.72 Millimeter
  • Length: 205.72 Millimeter
44935Z

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, single, D.ZAP(Z) T=30, for use with Frame and STar or MT Drive
FHC, INC.
34625Z-00249
In Commercial Distribution

  • 10873263002497 ()
  • 00873263002490 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
34625Z

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, single, DZAP(L) T=30, for use with Frame and STar or MT Drive
FHC, INC.
34625L-00248
In Commercial Distribution

  • 10873263002480 ()
  • 00873263002483 ()

  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 271.4 Millimeter
  • Impedance: Megaohms
34625L

  • Depth electrode
microTargeting(TM) Electrode, non sterile, 6x, Array, D.ZAP(Z), T=30 for use with frame, STar or MT Drive
FHC, INC.
22635Z-00241
In Commercial Distribution

  • 10873263002411 ()
  • 00873263002414 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
22635Z

  • Depth electrode
microTargeting(TM) Electrode, non-sterile, 6x, array, D.ZAP(L), T=30 for use with frame, STar or MT Drive
FHC, INC.
22635L-00240
In Commercial Distribution

  • 10873263002404 ()
  • 00873263002407 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
22635L

  • Depth electrode
microTargeting(TM) Electrode, 6x, non-sterile, Array, 1 Meg, T=30 for use with frame and STar or mT drive
FHC, INC.
22630R-00239
In Commercial Distribution

  • 10873263002398 ()
  • 00873263002391 ()

  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 261.5 Millimeter
  • Impedance: Megaohms
22630R

  • Depth electrode
microTargeting Electrode 6x, non-sterile, Array, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1003-00136
Not in Commercial Distribution

  • 10873263001360 ()
  • 00873263001363 ()

  • Length: 276.5 Millimeter
  • Length: 261.5 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
FC1003

  • Depth electrode
microTargeting Electrode 6x, non-sterile, Single, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1002-00135
Not in Commercial Distribution

  • 10873263001353 ()
  • 00873263001356 ()

  • Length: 271.4 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.77 Millimeter
  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
FC1002

  • Depth electrode
microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with Nexframe and STar Drive
FHC, INC.
FC2004-00129
Not in Commercial Distribution

  • 10873263001292 ()
  • 00873263001295 ()

  • Length: 227.2 Millimeter
  • Length: 242.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
FC2004

  • Depth electrode
microTargeting Differential Electrode 5x, Sterile, Single and Array, D.ZAP(L) , T=30 for use with NexFrame and MT Drive or NexDrive
FHC, INC.
FC2003-00128
Not in Commercial Distribution

  • 10873263001285 ()
  • 00873263001288 ()

  • Length: 249.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 234.2 Millimeter
  • Length: 10 Millimeter
FC2003

  • Depth electrode
microTargeting D.ZAP(L) Differential Electrode 5x, Sterile, Single, T=30 for use with Frame and STar or MT Drive
FHC, INC.
FC2002-00127
Not in Commercial Distribution

  • 10873263001278 ()
  • 00873263001271 ()

  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
FC2002

  • Depth electrode
microTargeting Differential Electrode 5x, D.ZAP(L), Sterile, Array, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC2001-00126
Not in Commercial Distribution

  • 10873263001261 ()
  • 00873263001264 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Length: 261.5 Millimeter
  • Length: 276.5 Millimeter
FC2001

  • Depth electrode
microTargeting Differential Electrode 5x, Sterile, Single, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
34680-00125
Not in Commercial Distribution

  • 10873263001254 ()
  • 00873263001257 ()

  • Impedance: Megaohms
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
34680

  • Depth electrode
microTargeting Differential Electrode 5x, Sterile, Array, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
22670-00124
Not in Commercial Distribution

  • 10873263001247 ()
  • 00873263001240 ()

  • Length: 261.5 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
22670

  • Depth electrode
microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT Drive or NexDrive.
FHC, INC.
FC5000-00117
Not in Commercial Distribution

  • 10873263001179 ()
  • 00873263001172 ()

  • Length: 249.2 Millimeter
  • Length: 10 Millimeter
  • Length: 234.2 Millimeter
  • Impedance: Megaohms
  • Length: 0.56 Millimeter
FC5000

  • Depth electrode
microTargeting™ Electrode, tungsten, non sterile, 6x, D.ZAP(Z)
FHC, INC.
MTDWZN(AR)(MP7)-00920
In Commercial Distribution

  • 00873263009208 ()
  • 10873263009205 ()
MTDWZN(AR)(MP7)

  • Depth electrode
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