OmniVersa

GUDID 00858703006139

Combination electrical stimulation/ultrasound for physical therapy

ACCELERATED CARE PLUS CORP

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00858703006139
• NIH Device Record Key: ec5f5db5-bec9-4625-a1c8-50c66ccccb24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniVersa
• Version Model Number: 100FXF
• Company DUNS: 828331616
• Company Name: ACCELERATED CARE PLUS CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com
• Phone: 800-850-1100
• Email: acp-customersupport@hanger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858703006139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153559

FDA Product Code

• IMG: Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

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

• 00858703006399 - OmniCycle Elite 7 Inch Screen Motorized Therapeutic Exercise System: 2024-10-29 Motorized therapy cycle with a 7 inch screen that can connect to the OmniTour system
• 00858703006382 - OmniTour System: 2024-09-18 Interactive cycling therapy feedback device.
• 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