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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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
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660179 ()
30684

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660162 ()
30683

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660155 ()
30682

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660148 ()
30681

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660117 ()
30005

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660100 ()
30004

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660094 ()
30003

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660087 ()
30002

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660070 ()
30001

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660063 ()
30000

  • Treadmill/elliptical gait rehabilitation system
Robotic-assisted gait trainer
Reha Technology AG
G-EO
In Commercial Distribution

  • 07640174420032 ()


  • Treadmill/elliptical gait rehabilitation system
Robotic-assisted gait trainer
Reha Technology AG
G-EO System
In Commercial Distribution

  • 07640174420018 ()


  • Treadmill/elliptical gait rehabilitation system
The Optimal-G is a robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The Optimal-G enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
A
In Commercial Distribution

  • 07290017844312 ()
OG01-0000-01

  • Gait rehabilitation system harness
The ReoAmbulator model is robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The ReoAmbulator enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
B
In Commercial Distribution

  • 07290017844305 ()
RA01-0000-00

  • Gait rehabilitation system harness
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290016450620 ()
  • 17290016450627 ()
366-901079-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290016450613 ()
  • 17290016450610 ()
366-901024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290016450606 ()
  • 17290016450603 ()
366-009024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290016450590 ()
  • 17290016450597 ()
366-009079-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290016450583 ()
  • 17290016450580 ()
366-090244-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290016450576 ()
  • 17290016450573 ()
366-922780-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290016450569 ()
  • 17290016450566 ()
366-921480-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290016450552 ()
  • 17290016450559 ()
366-901080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290016450545 ()
  • 17290016450542 ()
366-009081-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290016450538 ()
  • 17290016450535 ()
366-009023-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290016450521 ()
  • 17290016450528 ()
366-009080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290016450514 ()
  • 17290016450511 ()
366-22675L-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290016450507 ()
  • 17290016450504 ()
366-22675Z-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290016450491 ()
  • 17290016450498 ()
366-34685L-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290016450484 ()
  • 17290016450481 ()
366-34685Z-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290016450477 ()
  • 17290016450474 ()
366-000925-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290016450460 ()
  • 17290016450467 ()
366-000825-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290016450453 ()
  • 17290016450450 ()
366-000425-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290016450446 ()
  • 17290016450443 ()
366-000025-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290016450439 ()
  • 17290016450436 ()
366-001124-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290016450422 ()
  • 17290016450429 ()
366-001024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290016450415 ()
  • 17290016450412 ()
366-000024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290016450408 ()
  • 17290016450405 ()
366-000023-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290016450392 ()
  • 17290016450399 ()
366-107079-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290016450385 ()
  • 17290016450382 ()
366-001079-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290016450378 ()
  • 17290016450375 ()
366-000079-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290016450361 ()
  • 17290016450368 ()
366-001080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290016450354 ()
  • 17290016450351 ()
366-022780-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290016450347 ()
  • 17290016450344 ()
366-021480-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290016450330 ()
  • 17290016450337 ()
366-007080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290016450323 ()
  • 17290016450320 ()
366-000081-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290016450316 ()
  • 17290016450313 ()
366-000080-00

  • Depth electrode
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