FDA UDI
In Commercial Distribution
🇺🇸 United States
EksoUE
DI: B168EKSOUE0
·
Model: EKSOUE
·
EKSO BIONICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EksoUE
- Primary DI
- B168EKSOUE0
- Version / Model
- EKSOUE
- Catalog Number
- EKSOUE
- Company Name
- EKSO BIONICS, INC.
- Labeler DUNS
- 190152921
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-03
- Public Version
- 1
- Public Version Date
- 2022-03-11
- Public Version Status
- New
- Public Device Record Key
- 01422b72-03f4-4005-a33d-44f9b7fcafc3
Device Description
EKSO BIONICS SYSTEM, Ekso UE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PKS | Exerciser, Non-Measuring For Stroke Rehabilitation | Physical Medicine | 890.5370 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36314 | Shoulder continuous passive motion exerciser | A 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B168EKSOUE0 | HIBCC |