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Fora

FDA UDI

Class II (US FDA UDI)

by Fora Care Inc.

Identity

Trade Name
FORA FDA UDI
Generic Name
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Device Name
Blood Glucose Plus Blood Pressure Monitoring System FDA UDI
Model / Reference
D40 Pro FDA UDI
Description
Blood Glucose Plus Blood Pressure Monitoring System FDA UDI

Identifiers

Primary DI / UDI-DI
00816042012846 FDA UDI
510(k) Number
K101926 FDA UDI
FDA Product Code
DXN FDA UDI
NBW FDA UDI
GMDN Term
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
862.1345 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wristHome-use/point-of-care glucose analyser IVD, battery-powered

Fora by Fora Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home-use/point-of-care glucose analyser IVD, battery-powered.

Cleared under the same submission

K101926 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fora Care Inc.

Sources (1)

  • FDA UDI afab0732-9789-4186-a105-ff6784e1318b 34 fields · synced Jun 7, 2026