FDA UDI
In Commercial Distribution
🇺🇸 United States
SMART
DI: B179SEVBUN020
·
Model: DX EVO2
·
BTS SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SMART
- Primary DI
- B179SEVBUN020
- Version / Model
- DX EVO2
- Catalog Number
- SEVBUN02
- Company Name
- BTS SPA
- Labeler DUNS
- 428484518
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-20
- Public Version
- 1
- Public Version Date
- 2024-12-30
- Public Version Status
- New
- Public Device Record Key
- 7b664233-1393-4fc2-9d7f-63c295c11044
Device Description
SMART-DX EVOTVCcamera component of SMART that is a System for motion analysis, intended for the recording and analysis of human movement patterns in the. fields of rehabilitation, sports medicine, ergonomics, clinical research.
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
- No
- 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 |
|---|---|---|---|---|
| LXJ | System, Optical Position/Movement Recording | Physical Medicine | 890.5360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17929 | Biomechanical function analysis system, motion-tracking | A mains electricity (AC-powered) device assembly designed to track and evaluate the movement of the human body or body segments for the purpose of obtaining graphical visualization and biomechanical analysis of the body (e.g., spinal or joint movements). The device can also be used to determine the extent of ataxia (failure of muscular coordination) and will typically be used in the study of sports/work/rehabilitation related mechanisms/tasks; it is not dedicated to gait analysis alone. It may include various components to achieve its purpose [e.g., markers, sensors, video cameras, image processors, and computers]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B179SEVBUN020 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131660 | 000 |