Identity
- Trade Name
- F-Scan VersaTek Wireless FDA UDI
- Generic Name
- Body-surface pressure mapping system FDA UDI
- Device Name
- Includes 2 VersaTek Cuffs, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File, PDF of System Manual, Pre-configured wireless router, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini A/B USB Cable, (2) 4 ft. Cuff Cables, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (20) F-Scan 3000-E, (16) 3000SPORT-E, (14) 3001-E, -or- (12) 3001SPORT-E. FDA UDI
- Model / Reference
- F-Scan VersaTek Wireless System FDA UDI
- Description
- Includes 2 VersaTek Cuffs, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, F-Scan Clinical Software CD with F-Scan Map, Help File, PDF of System Manual, Pre-configured wireless router, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini A/B USB Cable, (2) 4 ft. Cuff Cables, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Case, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only). System includes one of the following Sensor selections: (20) F-Scan 3000-E, (16) 3000SPORT-E, (14) 3001-E, -or- (12) 3001SPORT-E. FDA UDI
Identifiers
- Catalog Number
- FVW2 FDA UDI
- Primary DI / UDI-DI
- B970FVW20 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
F-Scan VersaTek Wireless 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 d5916eb9-e7a1-4c99-93e3-aa0ba2539f50 34 fields · synced May 30, 2026