| Primary Device ID | 00867786000231 |
| NIH Device Record Key | a9264c10-9f9b-44fa-9f92-398f08dc0451 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMPCARE Restorative Posture Device |
| Version Model Number | RPD |
| Catalog Number | 50707 |
| Company DUNS | 013052325 |
| Company Name | AMPCARE, LLC |
| 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 | true |
| Serial Number | false |
| 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 | true |
| 00867786000231 - AMPCARE Restorative Posture Device | 2020-07-06Restorative Posture Device with pads. Orthosis device used in conjunction with AMPCARE's Effective Swallowing Protocol (ESP) to enhance swallowing treatment by assisting with proper position of head and neck, maintaining placement and improving electrical conduction of E Series Electrodes and providing a resistive exercise protocol. For single patient use. |
| 00867786000231 - AMPCARE Restorative Posture Device | 2020-07-06 Restorative Posture Device with pads. Orthosis device used in conjunction with AMPCARE's Effective Swallowing Protocol (ESP) to |
| 00867786000200 - E Series | 2018-07-06 Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patien |
| 10867786000214 - E Series | 2018-07-06 Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patien |