OmniVR Elite

GUDID 00858703006351

Virtual display rehabilitation system

ACCELERATED CARE PLUS CORP

Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical

• Primary Device ID: 00858703006351
• NIH Device Record Key: 89cc5d54-b876-41a2-9e89-27bd05c4e173
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniVR Elite
• Version Model Number: 300600C
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com
• Phone: 1-800-350-1100
• Email: acp-customersupport@hanger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858703006351 [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: 2023-09-11
• Device Publish Date: 2023-09-01

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: 2023-09-11Virtual display 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