| Device Type ID | 5117 |
| Device Name | Chair, Positioning, Electric |
| Regulation Description | Electric Positioning Chair. |
| 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 | 890.3110 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | INO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 5117 |
| Device | Chair, Positioning, Electric |
| Product Code | INO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Electric Positioning Chair. |
| CFR Regulation Number | 890.3110 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DALTON INSTRUMENT CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 81 |
Fire | 10 |
Smoking | 3 |
Device Operates Differently Than Expected | 2 |
Mechanical Problem | 2 |
Overheating Of Device | 1 |
Break | 1 |
Device Emits Odor | 1 |
Loss Of Power | 1 |
Material Protrusion / Extrusion | 1 |
Product Quality Problem | 1 |
Battery Problem | 1 |
Use Of Device Problem | 1 |
No Audible Alarm | 1 |
Unintended System Motion | 1 |
Self-Activation Or Keying | 1 |
Inadequate Service | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 111 |