Identity
- Trade Name
- OmniFlow Software FDA UDI
- Generic Name
- Bioelectrical signal analysis software FDA UDI
- Device Name
- Breathing therapy Biofeedback System FDA UDI
- Model / Reference
- FlowSoftware FDA UDI
- Description
- Breathing therapy Biofeedback System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858703006313 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 software
OmniFlow Software by Accelerated Care Plus Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bioelectrical signal analysis software.
- MyoVision Software — PRECISION BIOMETRICS INC · Class II
- SmartScreener-Plus2 Screener Launch — Intelligent Hearing Systems Corp. · Class II
- SmartDPOAE Software — Intelligent Hearing Systems Corp. · Class II
- encevis — AIT Austrian Institute of Technology GmbH · Class II
- MyoVision Software — PRECISION BIOMETRICS INC · Class II
- encevis — AIT Austrian Institute of Technology GmbH · Class II
- MyoVision Software — PRECISION BIOMETRICS INC · Class I
- CNS Envision — Natus Neurology Incorporated · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Accelerated Care Plus Corp.
Sources (1)
- FDA UDI 8d5e747c-37d2-4733-a1b9-547f2ad80c16 34 fields · synced Jun 7, 2026