OmniTour

FDA UDI

Class I (US FDA UDI)

by Accelerated Care Plus Corp.

Identity

Trade Name: OmniTour FDA UDI
Generic Name: Bioelectrical signal analysis software FDA UDI
Device Name: Therapy cycling feedback software FDA UDI
Model / Reference: OmniTourSoftware FDA UDI
Description: Therapy cycling feedback software FDA UDI

Identifiers

Primary DI / UDI-DI: 00858703006375 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Bioelectrical signal analysis software

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Accelerated Care Plus Corp.

Sources (1)

FDA UDI 7188a029-5217-4adb-81ce-abd1f72e1a23 34 fields · synced Jun 1, 2026