EksoUE

Primary DI
B168EKSOUE0
Brand
EksoUE
Company
Ekso Bionics, Inc.
Model
EKSOUE
Catalog number
EKSOUE
Device description
EKSO BIONICS SYSTEM, Ekso UE
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
PKSExerciser, Non-Measuring For Stroke Rehabilitation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKSExerciser, Non-Measuring For Stroke RehabilitationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B168EKSOUE0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder continuous passive motion exerciserA mains electricity (AC-powered) device designed to continuously move the shoulder joint (e.g., flexion, rotation, adduction/abduction) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joint. It typically consists of a motorized carriage with straps to hold and move the arm/shoulder, and an electrical control unit for the healthcare professional to set the variable range of motion and motion speed; digital displays, manual/automated safety capabilities, and other features may also be included. CPM is believed to stimulate articular tissues and circulation of synovial fluid, and to reduce joint oedema.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
190152921
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B168EKSONR0EksoNREKSONREKSONR2022-03-03
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
B1431200000EksoGT2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04041925002713THERA-Trainer balomedica - Medizintechnik GmbHPKS2023-10-23
04041925002720THERA-Trainer coromedica - Medizintechnik GmbHPKS2023-10-23
04041925002805OmniStandmedica - Medizintechnik GmbHPKS2023-09-01