Identity
- Trade Name
- CONFORMat VersaTek Wireless FDA UDI
- Generic Name
- Body-surface pressure mapping system FDA UDI
- Device Name
- Includes 1 VersaTek Cuff, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Line Filter, CONFORMat Clinical Software CD with CONFORMat Map, Help File, PDF of System Manual, Pre-configured wireless router, (1) 5330E Sensor, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, (1) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 1 Arm/Leg Strap, 1 Velcro Cable Tie, 1 Velcro Wrist/Ankle Band, Sensor Carrying Tube, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only) FDA UDI
- Model / Reference
- CONFORMat 1 VersaTek Wireless System FDA UDI
- Description
- Includes 1 VersaTek Cuff, 1 VersaTek Wireless Unit with Battery Pack Holder and Belt, Power Supply and AC Cord, Line Filter, CONFORMat Clinical Software CD with CONFORMat Map, Help File, PDF of System Manual, Pre-configured wireless router, (1) 5330E Sensor, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, (1) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 1 Arm/Leg Strap, 1 Velcro Cable Tie, 1 Velcro Wrist/Ankle Band, Sensor Carrying Tube, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only) FDA UDI
Identifiers
- Catalog Number
- CVW1 FDA UDI
- Primary DI / UDI-DI
- B970CVW10 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
CONFORMat 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 ae0db1f2-fa43-40f3-a2a9-91ead1551f1f 34 fields · synced May 30, 2026