Identity
- Trade Name
- Mobile Mat HR VersaTek FDA UDI
- Generic Name
- Body-surface pressure mapping system FDA UDI
- Device Name
- Includes 1 VersaTek 2-Port Hub, Power Supply and AC Cord, 10 ft. USB cable, (2) 10 ft. Cuff Cables, 2 built-in VersaTek Cuffs, FootMat Software for Clinicians CD with 7101E Map, Help File and PDF of System Manual, MobileMat HR 7101E Sensor installed in the MobileMat floor display, Quick Start Guide, and 1 Web-Based Training Session FDA UDI
- Model / Reference
- MobileMat HR Platform with FootMat Software for Clinicians FDA UDI
- Description
- Includes 1 VersaTek 2-Port Hub, Power Supply and AC Cord, 10 ft. USB cable, (2) 10 ft. Cuff Cables, 2 built-in VersaTek Cuffs, FootMat Software for Clinicians CD with 7101E Map, Help File and PDF of System Manual, MobileMat HR 7101E Sensor installed in the MobileMat floor display, Quick Start Guide, and 1 Web-Based Training Session FDA UDI
Identifiers
- Catalog Number
- MMatHR-CLINICAL FDA UDI
- Primary DI / UDI-DI
- B970MMATHRCLINICAL0 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
Mobile Mat HR 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 17200d70-419f-48a7-966a-0b6108896d8d 34 fields · synced May 31, 2026