| Primary Device ID | 00858703006399 |
| NIH Device Record Key | 1b96ac05-1445-4d02-b2be-ecd27cb01a9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OmniCycle Elite 7 Inch Screen Motorized Therapeutic Exercise System |
| Version Model Number | A007-533 |
| 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 |
| Phone | 1-800-350-1100 |
| acp-customersupport@hanger.com | |
| Phone | 1-800-350-1100 |
| acp-customersupport@hanger.com | |
| Phone | 1-800-350-1100 |
| acp-customersupport@hanger.com | |
| Phone | 1-800-350-1100 |
| acp-customersupport@hanger.com | |
| Phone | 1-800-350-1100 |
| acp-customersupport@hanger.com | |
| Phone | 1-800-350-1100 |
| acp-customersupport@hanger.com | |
| Phone | 1-800-350-1100 |
| acp-customersupport@hanger.com | |
| Phone | 1-800-350-1100 |
| acp-customersupport@hanger.com | |
| Phone | 1-800-350-1100 |
| acp-customersupport@hanger.com | |
| Phone | 1-800-350-1100 |
| acp-customersupport@hanger.com | |
| Phone | 1-800-350-1100 |
| acp-customersupport@hanger.com | |
| Phone | 1-800-350-1100 |
| acp-customersupport@hanger.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858703006399 [Primary] |
| BXB | Exerciser, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-29 |
| Device Publish Date | 2024-10-21 |
| 00858703006399 - OmniCycle Elite 7 Inch Screen Motorized Therapeutic Exercise System | 2024-10-29Motorized therapy cycle with a 7 inch screen that can connect to the OmniTour system |
| 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 |