Identity
- Trade Name
- MatScan VersaTek FDA UDI
- Generic Name
- Body-surface pressure mapping system FDA UDI
- Device Name
- Includes MatScan 3150E Sensor installed in floor display with 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, FootMat Software for Clinicians CD with MatScan 3150 Map, Help File and PDF of System Manual, 10 ft. USB Cable, 10 ft. Cuff Cable, and 1 Web-Based Training Session FDA UDI
- Model / Reference
- MatScan VersaTek Platform with FootMat Software for Clinicians FDA UDI
- Description
- Includes MatScan 3150E Sensor installed in floor display with 1 VersaTek Cuff, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, FootMat Software for Clinicians CD with MatScan 3150 Map, Help File and PDF of System Manual, 10 ft. USB Cable, 10 ft. Cuff Cable, and 1 Web-Based Training Session FDA UDI
Identifiers
- Catalog Number
- MV1 FDA UDI
- Primary DI / UDI-DI
- B970MV10 FDA UDI
- FDA Product Code
- JFC FDA UDI
- GMDN Term
- Body-surface pressure mapping system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.1600 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Body-surface pressure mapping system
MatScan VersaTek by Tekscan, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Tekscan, Inc.
Sources (1)
- FDA UDI 4b2ba1d7-455e-41c4-b330-27ab39ef0b21 34 fields · synced May 30, 2026