FDA UDI
In Commercial Distribution
🇺🇸 United States
Trexo Robotics
DI: 00628719321027
·
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
- 00628719321027
- Version / Model
- A0001
- Catalog Number
- A001BHR
- 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
- ba3cd22d-2680-4acb-8c60-bb3aa85993d4
Device Description
Trexo Robotics Large Trexo Home 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 |
|---|---|---|---|---|
| 60788 | Programmable ambulation exoskeleton, home-use | A battery-powered, pre-programmed, lower-limb orthosis system intended to enable a patient with a walking disability resulting from spinal cord injury to perform routine ambulatory functions (e.g., stand, walk, ascend and descend stairs); it may also be used to help promote intrinsic motor function. It is typically strapped to the patient over clothing and includes an exoskeleton structure made of metal, with electric motors, mechanical actuators and sensors, an on-board computer, and controls. It is intended for single-patient use, typically outside of a controlled setting following completion of training under professional supervision. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628719321027 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Large |