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 |