Anesthesiology
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- Cardiovascular Diagnostic DevicesCFR Sub-Part
- Cardiovascular Monitoring DevicesCFR Sub-Part
- Cardiovascular Therapeutic DevicesCFR Sub-Part
- Diagnostic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Neurological Diagnostic DevicesCFR Sub-Part
- Neurological Surgical DevicesCFR Sub-Part
- Neurological Therapeutic DevicesCFR Sub-Part
- Physical Medicine Diagnostic DevicesCFR Sub-Part
- Physical Medicine Prosthetic DevicesCFR Sub-Part
- PHLPowered Exoskeleton2Product Code
- K213452GEMS-H2Cleared 510(K)
- K201473ExoAtlet-II2Cleared 510(K)
- K201559HAL for Medical Use(Lower Limb type)2Cleared 510(K)
- K201539Keeogo Dermoskeleton System2Cleared 510(K)
- K200574EksoNR2Cleared 510(K)
- K200032ReWalk P6.02Cleared 510(K)
- K190337ReWalk Restore2Cleared 510(K)
- K183152Phoenix2Cleared 510(K)
- K181294Honda Walking Assist Device2Cleared 510(K)
- K173530Indego(R)2Cleared 510(K)
- Show All 17 Submissions
- Physical Medicine Therapeutic DevicesCFR Sub-Part
- Surgical DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
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- UnknownReview Panel
EksoNR
- Page Type
- Cleared 510(K)
- 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