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Presto-Scan Evolution

FDA UDI

Class I (US FDA UDI)

by Tekscan, Inc.

Identity

Trade Name
Presto-Scan Evolution FDA UDI
Generic Name
Body-surface pressure mapping system FDA UDI
Device Name
Includes 3140 Sensor installed in Presto-Scan display with 1 built in Evolution handle, (1) 10 ft. USB-A to USB-B cable, Presto-Scan Software CD with 3140 Map, and Quick Start Guide FDA UDI
Model / Reference
Presto-Scan System FDA UDI
Description
Includes 3140 Sensor installed in Presto-Scan display with 1 built in Evolution handle, (1) 10 ft. USB-A to USB-B cable, Presto-Scan Software CD with 3140 Map, and Quick Start Guide FDA UDI

Identifiers

Catalog Number
ZPKG-PRESTOSCAN-EVOLUTION FDA UDI
Primary DI / UDI-DI
B970ZPKGPRESTOSCANEVOL0 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

Presto-Scan Evolution 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 77a88122-ab9b-4ffe-adc2-dfadba0ca32a 34 fields · synced Jun 8, 2026