| Device Type ID | 5075 |
| Device Name | Bath, Sitz, Powered |
| Regulation Description | Immersion Hydrobath. |
| 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 | 890.5100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ILM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5075 |
| Device | Bath, Sitz, Powered |
| Product Code | ILM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Immersion Hydrobath. |
| CFR Regulation Number | 890.5100 [🔎] |
| Device Problems | |
|---|---|
Maintenance Does Not Comply To Manufacturers Recommendations | 28 |
Device Tipped Over | 17 |
Component Falling | 15 |
Installation-Related Problem | 13 |
Detachment Of Device Component | 11 |
Use Of Device Problem | 10 |
Adverse Event Without Identified Device Or Use Problem | 10 |
Device Operational Issue | 10 |
Unintended Movement | 7 |
Device Maintenance Issue | 6 |
Chemical Spillage | 5 |
Leak / Splash | 5 |
Human Factors Issue | 5 |
Detachment Of Device Or Device Component | 5 |
Device Dislodged Or Dislocated | 5 |
Unstable | 4 |
Temperature Problem | 4 |
Shelf Life Exceeded | 4 |
Microbial Contamination Of Device | 3 |
Break | 3 |
Environmental Compatibility Problem | 3 |
Biofilm Coating In Device | 3 |
Smoking | 2 |
Calibration Problem | 2 |
Overheating Of Device | 2 |
Positioning Problem | 2 |
Crack | 1 |
Filling Problem | 1 |
Mechanical Jam | 1 |
Component Incompatible | 1 |
Use Of Incorrect Control Settings | 1 |
Failure To Disinfect | 1 |
Hole In Material | 1 |
Knob | 1 |
Overfill | 1 |
Battery Problem | 1 |
Device Inoperable | 1 |
| Total Device Problems | 195 |