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OmniFlow Therapy System

FDA UDI

Class I (US FDA UDI)

by Accelerated Care Plus Corp.

Identity

Trade Name
OmniFlow Therapy System FDA UDI
Generic Name
Bioelectrical signal analysis software FDA UDI
Device Name
Software and sensor designed to provide visual feedback to respiratory patients. FDA UDI
Model / Reference
100FLO FDA UDI
Description
Software and sensor designed to provide visual feedback to respiratory patients. FDA UDI

Identifiers

Primary DI / UDI-DI
00858703006276 FDA UDI
FDA Product Code
ION FDA UDI
GMDN Term
Bioelectrical signal analysis software FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.5370 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

Yes

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: Bioelectrical signal analysis softwareMonitoring spirometer, mechanicalBiomechanical function analysis/interactive rehabilitation system

OmniFlow Therapy System by Accelerated Care Plus Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Biomechanical function analysis/interactive rehabilitation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Accelerated Care Plus Corp.

Sources (1)

  • FDA UDI 5e38854b-e1ec-48b1-88ac-9207f35acd4e 33 fields · synced May 30, 2026