| Device Type ID | 5115 |
| Device Name | Chair, With Casters |
| Regulation Description | Mechanical 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 | 890.3100 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | INM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5115 |
| Device | Chair, With Casters |
| Product Code | INM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Mechanical Chair. |
| CFR Regulation Number | 890.3100 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 7 |
Use Of Device Problem | 7 |
Unintended Movement | 5 |
Defective Component | 4 |
Device Inoperable | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Device Fell | 1 |
Device Operates Differently Than Expected | 1 |
Device Tipped Over | 1 |
Loss Of Or Failure To Bond | 1 |
Electrical /Electronic Property Problem | 1 |
Device-Device Incompatibility | 1 |
Electrical Shorting | 1 |
Expulsion | 1 |
Human Factors Issue | 1 |
Channeling | 1 |
Component(s), Broken | 1 |
Mechanical Problem | 1 |
Overheating Of Device | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 41 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Nemschoff Chairs, Inc. | II | Oct-06-2014 |
| 2 | R82 A/S | II | Nov-09-2018 |
| 3 | Winco Mfg., LLC | II | Feb-26-2014 |