Identity
- Trade Name
- HR Mat VersaTek FDA UDI
- Generic Name
- Body-surface pressure mapping system FDA UDI
- Device Name
- Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Linking Cable, FootMat Software for Clinicians CD with 7101E Map, Help File and PDF of System Manual, HR Mat 7101E Sensor installed in floor display, 10 ft. USB Cable, (2) 10 ft. Cuff Cables, Quick Start Guide, and 1 Web-Based Training Session FDA UDI
- Model / Reference
- HR Mat VersaTek Platform with FootMat Software for Clinicians FDA UDI
- Description
- Includes 2 VersaTek Cuffs, 1 VersaTek 2-Port Hub, Power Supply and AC Cord, Linking Cable, FootMat Software for Clinicians CD with 7101E Map, Help File and PDF of System Manual, HR Mat 7101E Sensor installed in floor display, 10 ft. USB Cable, (2) 10 ft. Cuff Cables, Quick Start Guide, and 1 Web-Based Training Session FDA UDI
Identifiers
- Catalog Number
- HRV1 FDA UDI
- Primary DI / UDI-DI
- B970HRV10 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
HR Mat 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 bfb08501-6eb4-4c23-8bf1-13cd24ef48f9 34 fields · synced Jun 8, 2026