| Device Type ID | 5078 |
| Device Name | System, Communication, Powered |
| Regulation Description | Powered Communication System. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Physical Medicine |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 890.3710 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ILQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5078 |
| Device | System, Communication, Powered |
| Product Code | ILQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Communication System. |
| CFR Regulation Number | 890.3710 [🔎] |
| Device Problems | |
|---|---|
Computer Software Problem | 2 |
Material Integrity Problem | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Dynavox Systems Llc | II | Apr-03-2018 |
| 2 | Lifeline Systems Company | II | Apr-06-2018 |
| 3 | Lifeline Systems, Incorporated | II | Oct-01-2015 |
| 4 | Lifeline Systems, Incorporated | II | Jul-06-2015 |
| 5 | Stanley Security Solutions Inc | II | Mar-20-2017 |