| Device Type ID | 5073 |
| Device Name | Bath, Hydro-massage |
| 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 | ILJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5073 |
| Device | Bath, Hydro-massage |
| Product Code | ILJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Immersion Hydrobath. |
| CFR Regulation Number | 890.5100 [🔎] |
| Device Problems | |
|---|---|
Microbial Contamination Of Device | 12 |
Component Falling | 9 |
Device Fell | 6 |
Device Tipped Over | 4 |
Maintenance Does Not Comply To Manufacturers Recommendations | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Mechanical Problem | 3 |
Leak / Splash | 3 |
Installation-Related Problem | 3 |
Chemical Spillage | 2 |
Unintended Movement | 2 |
Failure To Align | 2 |
Misassembled | 2 |
Unintended System Motion | 2 |
Electrical /Electronic Property Problem | 1 |
Difficult To Open Or Close | 1 |
Device Dislodged Or Dislocated | 1 |
Use Of Device Problem | 1 |
Component Missing | 1 |
Device Inoperable | 1 |
Safety Interlock(s) Inadequate | 1 |
Migration | 1 |
Fracture | 1 |
Migration Or Expulsion Of Device | 1 |
Device Operates Differently Than Expected | 1 |
Device Operational Issue | 1 |
Unintended Electrical Shock | 1 |
Detachment Of Device Or Device Component | 1 |
Insufficient Information | 1 |
Break | 1 |
Display Or Visual Feedback Problem | 1 |
Inability To Irrigate | 1 |
Detachment Of Device Component | 1 |
Device Contamination With Biological Material | 1 |
Arcing | 1 |
Mechanical Jam | 1 |
Device Issue | 1 |
| Total Device Problems | 79 |