Identity
- Trade Name
- HR Walkway VersaTek FDA UDI
- Generic Name
- Body-surface pressure mapping system FDA UDI
- Device Name
- Includes 12 VersaTek Cuffs, 6 VersaTek 2-Port Hubs, 6 Power Supplies, 1 Multi-Port Powered USB Hub, Walkway Software CD with 7101HL Map and 3 Equilibration Files, Help File and PDF of System Manual, 6 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, 6 linking and 4 - 1 in. USB cables, Wooden Shipping Crate, and 1 Training Session (USA Only) FDA UDI
- Model / Reference
- HR Walkway 6 VersaTek System FDA UDI
- Description
- Includes 12 VersaTek Cuffs, 6 VersaTek 2-Port Hubs, 6 Power Supplies, 1 Multi-Port Powered USB Hub, Walkway Software CD with 7101HL Map and 3 Equilibration Files, Help File and PDF of System Manual, 6 HR Mat 7101E Sensors (pre-assembled into a single floor display), Hub Enclosure, 6 linking and 4 - 1 in. USB cables, Wooden Shipping Crate, and 1 Training Session (USA Only) FDA UDI
Identifiers
- Catalog Number
- HRV6 FDA UDI
- Primary DI / UDI-DI
- B970HRV60 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 Walkway 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 57e49d7b-4849-4235-87f1-d732df8de9df 34 fields · synced Jun 8, 2026