| Device Type ID | 5079 |
| Device Name | Adaptor, Hygiene |
| Regulation Description | Daily Activity Assist Device. |
| 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 | 890.5050 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | ILS |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5079 |
| Device | Adaptor, Hygiene |
| Product Code | ILS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Daily Activity Assist Device. |
| CFR Regulation Number | 890.5050 [🔎] |
| Device Problems | |
|---|---|
Break | 132 |
Unstable | 83 |
Crack | 74 |
Bent | 51 |
Collapse | 26 |
Product Quality Problem | 23 |
Detachment Of Device Component | 13 |
Adverse Event Without Identified Device Or Use Problem | 12 |
Material Integrity Problem | 11 |
Deformation Due To Compressive Stress | 10 |
Out-Of-Box Failure | 10 |
Unraveled Material | 8 |
Mechanical Jam | 7 |
Fracture | 6 |
Device Operates Differently Than Expected | 5 |
Frame | 5 |
Unintended Movement | 5 |
Torn Material | 5 |
Leak / Splash | 4 |
Connection Problem | 4 |
Device Dislodged Or Dislocated | 3 |
Use Of Device Problem | 3 |
Device Inoperable | 3 |
Improper Or Incorrect Procedure Or Method | 2 |
Component Missing | 2 |
Material Separation | 2 |
Calibration Problem | 2 |
Bolus Mechanism Failure | 2 |
Temperature Problem | 2 |
Split | 2 |
Component Falling | 2 |
Device Damaged Prior To Use | 2 |
Defective Device | 1 |
Mechanical Problem | 1 |
Device Slipped | 1 |
Failure To Align | 1 |
Detachment Of Device Or Device Component | 1 |
Insufficient Information | 1 |
Missing Value Reason | 1 |
Misassembly By Users | 1 |
Computer Operating System Problem | 1 |
Sticking | 1 |
Material Deformation | 1 |
Knob | 1 |
Device Tipped Over | 1 |
Material Frayed | 1 |
Inadequate Service | 1 |
Weld | 1 |
Defective Component | 1 |
Material Twisted / Bent | 1 |
Bolt | 1 |
| Total Device Problems | 540 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Etac Supply Center Ab | II | Aug-13-2015 |
| 2 | Etac Supply Center Ab | II | Jul-15-2015 |