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Versatek Wireless

FDA UDI

Class I (US FDA UDI)

by Tekscan, Inc.

Identity

Trade Name
Versatek Wireless FDA UDI
Generic Name
Body-surface pressure mapping system FDA UDI
Device Name
1 VersaTek Wireless Unit with Battery Pack Holder and Belt FDA UDI
Model / Reference
Versatek Wireless FDA UDI
Description
1 VersaTek Wireless Unit with Battery Pack Holder and Belt FDA UDI

Identifiers

Catalog Number
VW-1 FDA UDI
Primary DI / UDI-DI
B970VW10 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Body-surface pressure mapping system

Versatek Wireless by Tekscan, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body-surface pressure mapping system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tekscan, Inc.

Sources (1)

  • FDA UDI 5e733b9b-49e8-4572-9c04-3b26a5ba5549 34 fields · synced May 30, 2026