OmniME

GUDID 00858703006320

Multi-exercise respiratory therapy device with OmniFlow software and sensor, and Synchrony software, electrodes, and sensing devices

ACCELERATED CARE PLUS CORP

Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software

• Primary Device ID: 00858703006320
• NIH Device Record Key: adca2900-8801-40d4-9a99-79ff782d11b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniME
• Version Model Number: 100MTS
• Company DUNS: 828331616
• Company Name: ACCELERATED CARE PLUS CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-350-1100
• Email: acp-customersupport@hanger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858703006320 [Primary]

FDA Product Code

• ION: Exerciser, Non-Measuring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-25
• Device Publish Date: 2023-08-17

Devices Manufactured by ACCELERATED CARE PLUS CORP

• 00858703006375 - OmniTour: 2023-12-04 Therapy cycling feedback software
• 00858703006313 - OmniFlow Software: 2023-09-14 Respiratory assessment and exercise software
• B179OMNI13E87E4 - OmnisEMG: 2023-09-14 Biomechanical function analysis / interactive rehabilitation system
• 00858703006337 - Synchrony Dysphagia Solutions by ACP: 2023-09-11 Bioelectrical signal analysis software; Biomechanical function analysis, interactive rehabilitation system
• 00858703006351 - OmniVR Elite: 2023-09-11 Virtual display rehabilitation system
• 04041925002799 - OmniCycle Elite: 2023-09-11 Powered exercise therapy bicycle
• 04041925002805 - OmniStand: 2023-09-11 Exerciser, non-measuring for stroke rehabilitation
• 00858703006139 - OmniVersa: 2023-08-25 Combination electrical stimulation/ultrasound for physical therapy