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F-Scan64

FDA UDI

Class I (US FDA UDI)

by Tekscan, Inc.

Identity

Trade Name
F-Scan64 FDA UDI
Generic Name
Body-surface pressure mapping system FDA UDI
Device Name
Includes 2 F-Scan64 Cuffs, 1 Bluetooth Dongle, 2 Power Supply and AC Cords, F-Scan64 Software with all F-Scan64 sensor maps, 2 Velcro Cuff Straps, and F-Scan64 Sensors FDA UDI
Model / Reference
F-Scan64 System FDA UDI
Description
Includes 2 F-Scan64 Cuffs, 1 Bluetooth Dongle, 2 Power Supply and AC Cords, F-Scan64 Software with all F-Scan64 sensor maps, 2 Velcro Cuff Straps, and F-Scan64 Sensors FDA UDI

Identifiers

Catalog Number
F-SCAN64 FDA UDI
Primary DI / UDI-DI
B970FSCAN640 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-Scan64 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 61882706-00bf-45c0-b844-97701bc58a4d 34 fields · synced May 30, 2026