CONFORMat VersaTek Wireless

FDA UDI

Class I (US FDA UDI)

by Tekscan, Inc.

Identity

Trade Name: CONFORMat 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, Line Filter, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File, PDF of System Manual and Wireless software features, Pre-configured wireless router, (2) 5330E Sensors, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, (2) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Tube, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only) FDA UDI
Model / Reference: CONFORMat 2 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, Line Filter, CONFORMat Clinical Software CD with CONFORMat and CONFORMat Dual Maps, Help File, PDF of System Manual and Wireless software features, Pre-configured wireless router, (2) 5330E Sensors, Li-Ion Battery Pack, Battery Pack Charger and Battery Pack Charger Power Supply, 6.5 ft. Mini USB Cable, (2) 4 ft. Cuff Cables, Elastic Take-Up Belt, Elastic Belt Extension, 2 Arm/Leg Straps, 2 Velcro Cable Ties, 2 Velcro Wrist/Ankle Bands, Sensor Carrying Tube, System Carrying Case, Quick Start Guide, and 1 Training Session (USA Only) FDA UDI

Identifiers

Catalog Number: CVW2 FDA UDI
Primary DI / UDI-DI: B970CVW20 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

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 91d55b9d-4b80-4bdb-bf23-7ff135f98906 34 fields · synced Jun 8, 2026