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by
Innolitics
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PHL
Powered Exoskeleton
2
Product Code
K
21
3452
GEMS-H
2
Cleared 510(K)
K
20
1473
ExoAtlet-II
2
Cleared 510(K)
K
20
1559
HAL for Medical Use(Lower Limb type)
2
Cleared 510(K)
K
20
1539
Keeogo Dermoskeleton System
2
Cleared 510(K)
K
20
0574
EksoNR
2
Cleared 510(K)
K
20
0032
ReWalk P6.0
2
Cleared 510(K)
K
19
0337
ReWalk Restore
2
Cleared 510(K)
K
18
3152
Phoenix
2
Cleared 510(K)
K
18
1294
Honda Walking Assist Device
2
Cleared 510(K)
K
17
3530
Indego(R)
2
Cleared 510(K)
Show All 17 Submissions
Physical Medicine Therapeutic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
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CFR Sub-Part
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Review Panel
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Review Panel
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Unknown
Review Panel
Last synced on 9 June 2023 at 11:04 pm
NE
/
physical-medicine-prosthetic-devices
/
PHL
/
K200574
View Source
EksoNR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200574
510(k) Type
Traditional
Applicant
Ekso Bionics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/19/2020
Days to Decision
106 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Cardiovascular Diagnostic Devices
Cardiovascular Monitoring Devices
Cardiovascular Therapeutic Devices
Diagnostic Devices
Miscellaneous
Neurological Diagnostic Devices
Neurological Surgical Devices
Neurological Therapeutic Devices
Physical Medicine Diagnostic Devices
Physical Medicine Prosthetic Devices
PHL
Powered Exoskeleton
K
21
3452
GEMS-H
K
20
1473
ExoAtlet-II
K
20
1559
HAL for Medical Use(Lower Limb type)
K
20
1539
Keeogo Dermoskeleton System
K
20
0574
EksoNR
K
20
0032
ReWalk P6.0
K
19
0337
ReWalk Restore
K
18
3152
Phoenix
K
18
1294
Honda Walking Assist Device
K
17
3530
Indego(R)
Show All 17 Submissions
Physical Medicine Therapeutic Devices
Surgical Devices
Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
physical-medicine-prosthetic-devices
/
PHL
/
K200574
View Source
EksoNR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K200574
510(k) Type
Traditional
Applicant
Ekso Bionics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/19/2020
Days to Decision
106 days
Submission Type
Summary