Identity
- Trade Name
- SMART FDA UDI
- Generic Name
- Biomechanical function analysis system, motion-tracking FDA UDI
- Device Name
- SMART-DX EVO TVC camera 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. FDA UDI
- Model / Reference
- DX EVO5 FDA UDI
- Description
- SMART-DX EVO TVC camera 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. FDA UDI
Identifiers
- Catalog Number
- SEVBUN05 FDA UDI
- Primary DI / UDI-DI
- B179SEVBUN050 FDA UDI
- 510(k) Number
- K131660 FDA UDI
- FDA Product Code
- LXJ FDA UDI
- GMDN Term
- Biomechanical function analysis system, motion-tracking FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Biomechanical function analysis system, motion-tracking
Smart by Bts Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biomechanical function analysis system, motion-tracking.
- DS6 — FORESITE HEALTHCARE, LLC · Class II
- MDS — FORESITE HEALTHCARE, LLC · Class II
- DS5 — FORESITE HEALTHCARE, LLC · Class II
- DataLINK DLK900 — BIOMETRICS LIMITED · Class I
- Insight Discovery Dual Inclinometer — SRS Medical Systems, Inc. · Class II
- Discovery Base Unit — SRS Medical Systems, Inc. · Class II
- DS6 — FORESITE HEALTHCARE, LLC · Class II
- DS6 — FORESITE HEALTHCARE, LLC · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bts Spa
Sources (1)
- FDA UDI 77b588be-e87c-459b-af96-b9e909bf18d6 35 fields · synced Jun 8, 2026