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Vu

FDA UDI

Class I (US FDA UDI)

by Wellsense, Inc.

Identity

Trade Name
VU FDA UDI
Generic Name
Body-surface pressure mapping system FDA UDI
Device Name
The VU System provides real-time images of the contact pressure profile under a patient in a bed-care setting. This feedback helps caregivers to successfully offload pressure, which substantially reduces the risk of pressure injuries. FDA UDI
Model / Reference
WS-MAT-200-02 FDA UDI
Description
The VU System provides real-time images of the contact pressure profile under a patient in a bed-care setting. This feedback helps caregivers to successfully offload pressure, which substantially reduces the risk of pressure injuries. FDA UDI

Identifiers

Primary DI / UDI-DI
00860009142909 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

No

FDA UDI

Category: Body-surface pressure mapping system

Vu by Wellsense, 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
Wellsense, Inc.

Sources (1)

  • FDA UDI e211d828-e985-492a-bcae-06fccaa07a25 33 fields · synced Jun 8, 2026