| Device Type ID | 2659 |
| Device Name | Bed, Therapeutic, Ac-powered, Adjustable Home-use |
| Regulation Description | AC-powered Adjustable Hospital Bed. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.5100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LLI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2659 |
| Device | Bed, Therapeutic, Ac-powered, Adjustable Home-use |
| Product Code | LLI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | AC-powered Adjustable Hospital Bed. |
| CFR Regulation Number | 880.5100 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 20 |
Detachment Of Device Component | 8 |
Unintended Movement | 8 |
Misassembled | 5 |
Unstable | 5 |
Break | 4 |
Temperature Problem | 4 |
Insufficient Information | 4 |
Use Of Device Problem | 3 |
Component Missing | 2 |
No Apparent Adverse Event | 2 |
Unintended System Motion | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Material Integrity Problem | 2 |
Missing Value Reason | 2 |
Kinked | 2 |
Loose Or Intermittent Connection | 2 |
Device Maintenance Issue | 2 |
Device Issue | 2 |
Material Protrusion / Extrusion | 2 |
Material Torqued | 1 |
Device Handling Problem | 1 |
Installation-Related Problem | 1 |
Material Fragmentation | 1 |
Component Falling | 1 |
Separation Problem | 1 |
Mechanical Problem | 1 |
Device Slipped | 1 |
Detachment Of Device Or Device Component | 1 |
Misconnection | 1 |
Product Quality Problem | 1 |
Device Inoperable | 1 |
Patient-Device Incompatibility | 1 |
Device Operates Differently Than Expected | 1 |
Weld | 1 |
| Total Device Problems | 98 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Invacare Corporation | II | Feb-09-2017 |