FDA.reportPublic FDA data

EksoNR

Primary DI
B168EKSONR0
Brand
EksoNR
Company
Ekso Bionics, Inc.
Model
EKSONR
Catalog number
EKSONR
Device description
EKSO BIONICS SYSTEM, Ekso NR
Published
2022-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PHLPowered Exoskeleton

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHLPowered ExoskeletonPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200574000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200574000EksoNREkso Bionics, Inc.2020-06-19PHL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B168EKSONR0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Programmable ambulation exoskeleton, clinicalA battery-powered, pre-programmed, lower-limb orthosis system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function by manipulating the legs through a normal walking pattern during ambulation. The system includes an exoskeleton structure made of metal with electric motors, mechanical actuators, and sensors for feedback; it is typically strapped to the legs over clothing. It is intended for multiple-patient use, in a controlled clinical setting (e.g., gait lab, rehabilitation centre) under healthcare professional supervision.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
190152921
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B168501100000Indego501-100-0002025-07-01
B168501110001Indego Therapy501-110-0012025-07-01
M704501100000Indego501-100-0002016-09-15
M704501110001Indego Therapy501-110-0012018-08-27
B168EKSOGT0EksoGTEKSOGTEKSOGT2022-03-03
B168EKSOUE0EksoUEEKSOUEEKSOUE2022-03-03
B1431200000EksoGT2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03665965000167Atalante XWANDERCRAFTPHL2026-05-13
04560340091435Medical HAL Lower Limb TypeCYBERDYNE, INC.PHL2026-04-22
00860001744521ReWalk 7 Personal Exoskeleton Therapist Handheld DeviceLIFEWARD LTDPHL2025-09-17
B168501100000IndegoEkso Bionics, Inc.PHL2025-07-01
B168501110001Indego TherapyEkso Bionics, Inc.PHL2025-07-01
00860001744514ReWalk 7 Personal ExoskeletonLIFEWARD LTDPHL2025-04-15
18800140400031ExoAtlet®-IICOSMO ROBOTICS CO., Ltd.PHL2025-01-17
00860003478714TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESPHL2024-07-06
00860003478738TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESPHL2024-07-06
00860003478776TraumaGuard Intra-abdominal Pressure-Sensing SystemSENTINEL MEDICAL TECHNOLOGIESPHL2024-07-06
03665965000129Atalante XWANDERCRAFTPHL2023-03-13
B168EKSOGT0EksoGTEkso Bionics, Inc.PHL2022-03-03
07540162060007KEEOGO - CLINICIAN KITB-Temia IncPHL2021-06-16
00860001744507ReStoreLIFEWARD LTDPHL2019-10-16
04560340090940HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
04560340090957HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
04560340090964HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
04560340090971HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
04560340091060HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
04560340091077HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
04560340091084HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
04560340091091HAL for Medical UseCYBERDYNE, INC.PHL2019-02-01
M704501110001Indego TherapyEkso Bionics, Inc.PHL2018-08-27
B1431200000EksoEkso Bionics, Inc.PHL2016-09-23
M704501100000IndegoEkso Bionics, Inc.PHL2016-09-15
00861803000303ReWalk(TM) Personal 6.0LIFEWARD LTDPHL2016-09-08
00861803000310ReWalk(TM) PersonalLIFEWARD LTDPHL2016-09-08
00861803000327ReWalk(TM) RehabilitaitonLIFEWARD LTDPHL2016-09-08