| Device Type ID | 5188 |
| Device Name | Walker, Mechanical |
| Regulation Description | Mechanical Walker. |
| 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 | 890.3825 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | ITJ |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5188 |
| Device | Walker, Mechanical |
| Product Code | ITJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Mechanical Walker. |
| CFR Regulation Number | 890.3825 [🔎] |
| Device Problems | |
|---|---|
Break | 280 |
Unstable | 248 |
Bent | 59 |
Product Quality Problem | 55 |
Detachment Of Device Component | 53 |
Adverse Event Without Identified Device Or Use Problem | 42 |
Crack | 38 |
Collapse | 32 |
Unintended Movement | 23 |
Out-Of-Box Failure | 22 |
Fracture | 18 |
Deformation Due To Compressive Stress | 16 |
Naturally Worn | 15 |
Detachment Of Device Or Device Component | 14 |
Mechanical Jam | 14 |
Device Operates Differently Than Expected | 13 |
Device Inoperable | 12 |
Solder Joint Fracture | 12 |
Material Integrity Problem | 12 |
Use Of Device Problem | 11 |
Brake | 7 |
Improper Or Incorrect Procedure Or Method | 6 |
Wheel | 6 |
Insufficient Information | 5 |
Caster | 5 |
Frame | 4 |
Mechanical Problem | 4 |
Bolus Mechanism Failure | 4 |
Material Separation | 4 |
Device Issue | 4 |
Device Maintenance Issue | 3 |
Device Tipped Over | 3 |
Physical Property Issue | 2 |
Material Deformation | 2 |
Locking Mechanism | 2 |
Misassembly By Users | 2 |
Loose Or Intermittent Connection | 2 |
Device Damaged Prior To Use | 1 |
Device Unsafe To Use In Environment | 1 |
Material Distortion | 1 |
Mechanics Altered | 1 |
Device Slipped | 1 |
Missing Value Reason | 1 |
Noise, Audible | 1 |
Device Handling Problem | 1 |
Patient Device Interaction Problem | 1 |
Material Fragmentation | 1 |
Off-Label Use | 1 |
Human Factors Issue | 1 |
Installation-Related Problem | 1 |
Material Protrusion / Extrusion | 1 |
Accessory Incompatible | 1 |
Sticking | 1 |
Difficult To Fold Or Unfold | 1 |
Appropriate Term/Code Not Available | 1 |
Device Dislodged Or Dislocated | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Component Missing | 1 |
Structural Problem | 1 |
Barrier | 1 |
Bearings | 1 |
Misassembled | 1 |
Inadequate Service | 1 |
Weld | 1 |
Lock | 1 |
Defective Component | 1 |
Mechanism | 1 |
Bolt | 1 |
Material Disintegration | 1 |
Device Operational Issue | 1 |
Material Twisted / Bent | 1 |
Device Component Or Accessory | 1 |
| Total Device Problems | 1089 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Briggs Medical Service Company D.b.a. Mabis | II | Oct-28-2014 |
| 2 | Central Purchasing LLC DBA Harbor Freight Tools | II | Apr-10-2014 |
| 3 | Nova Ortho-Med Inc | II | Oct-24-2016 |
| 4 | Owens & Minor Distribution, Inc. | II | Nov-20-2014 |
| 5 | Roscoe Medical Inc | II | Nov-12-2014 |
| 6 | SVS LLC | II | Nov-20-2018 |