| Device Type ID | 5065 |
| Device Name | Aid, Transfer |
| 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 | IKX |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5065 |
| Device | Aid, Transfer |
| Product Code | IKX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Daily Activity Assist Device. |
| CFR Regulation Number | 890.5050 [🔎] |
| Device Problems | |
|---|---|
Break | 33 |
Use Of Device Problem | 19 |
Detachment Of Device Component | 9 |
Off-Label Use | 4 |
Detachment Of Device Or Device Component | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Unstable | 3 |
Bent | 3 |
Crack | 3 |
Inadequate Or Insufficient Training | 3 |
Device Issue | 3 |
Human Factors Issue | 2 |
Material Separation | 2 |
Device Slipped | 2 |
Fracture | 2 |
Device Component Or Accessory | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Solder Joint Fracture | 2 |
Material Integrity Problem | 1 |
Mechanism | 1 |
Pin | 1 |
Failure To Adhere Or Bond | 1 |
Brake | 1 |
Device Operates Differently Than Expected | 1 |
Weld | 1 |
Mount | 1 |
Deformation Due To Compressive Stress | 1 |
Physical Property Issue | 1 |
Material Split, Cut Or Torn | 1 |
Mechanical Problem | 1 |
Torn Material | 1 |
Out-Of-Box Failure | 1 |
Locking Mechanism | 1 |
Device Handling Problem | 1 |
Difficult To Fold Or Unfold | 1 |
| Total Device Problems | 119 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | EOS Imaging | II | Jun-23-2017 |
| 2 | Handicare USA, Inc. | II | Oct-24-2016 |
| 3 | Handicare USA, Inc. | II | May-14-2015 |
| 4 | Medline Industries Inc | II | Nov-21-2017 |