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OmniME

FDA UDI

Class I (US FDA UDI)

by Accelerated Care Plus Corp.

Identity

Trade Name
OmniME FDA UDI
Generic Name
Bioelectrical signal analysis software FDA UDI
Device Name
Multi-exercise respiratory therapy device with OmniFlow software and sensor, and Synchrony software, electrodes, and sensing devices FDA UDI
Model / Reference
100MTS FDA UDI
Description
Multi-exercise respiratory therapy device with OmniFlow software and sensor, and Synchrony software, electrodes, and sensing devices FDA UDI

Identifiers

Primary DI / UDI-DI
00858703006320 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

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

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

OmniME 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 adca2900-8801-40d4-9a99-79ff782d11b5 34 fields · synced May 30, 2026