FDA UDI
In Commercial Distribution
🇺🇸 United States
Trexo Robotics
DI: 00628719321065
·
Model: A0001
·
Trexo Robotics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trexo Robotics
- Primary DI
- 00628719321065
- Version / Model
- A0001
- Catalog Number
- A001BPR
- Company Name
- Trexo Robotics Inc.
- Labeler DUNS
- 242663041
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-05
- Public Version
- 1
- Public Version Date
- 2024-02-13
- Public Version Status
- New
- Public Device Record Key
- 1560079f-bfca-4861-b75c-365235049f7f
Device Description
Trexo Robotics Large Trexo Plus 1 Shipment
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | Physical Medicine | 890.1925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58943 | Programmable ambulation exoskeleton, clinical | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628719321065 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Large |