| Device Type ID | 5146 |
| Device Name | System, Environmental Control, Powered |
| Regulation Description | Powered Environmental Control 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 | 890.3725 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IQA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5146 |
| Device | System, Environmental Control, Powered |
| Product Code | IQA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Environmental Control System. |
| CFR Regulation Number | 890.3725 [🔎] |
| Device Problems | |
|---|---|
Low Battery | 1 |
Loss Of Data | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ascom (US) Inc. | II | Nov-20-2018 |