| Primary Device ID | B179OMNI13E87E4 |
| NIH Device Record Key | b708bd16-e382-4bf0-a6bc-e9fa4c9c5319 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OmnisEMG |
| Version Model Number | 44144 |
| 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 | |
| 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 |
|---|---|
| HIBCC | B179OMNI13E87E4 [Primary] |
| HCC | Device, Biofeedback |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-14 |
| Device Publish Date | 2023-09-06 |
| 00858703006375 - OmniTour | 2023-12-04 Therapy cycling feedback software |
| 00858703006313 - OmniFlow Software | 2023-09-14 Respiratory assessment and exercise software |
| B179OMNI13E87E4 - OmnisEMG | 2023-09-14Biomechanical function analysis / interactive rehabilitation system |
| 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 |