Definition: A Powered Exoskeleton Is A Prescription Device That Is Composed Of An External, Powered, Motorized Orthosis That Is Placed Over A Person's Paralyzed Or Weakened Lower Extremity Limb(s) For Medical Purposes.
| Device Type ID | 3824 |
| Device Name | Powered Exoskeleton |
| Physical State | The Device Is Comprised Of External, Powered, Orthotic Components That Rely On Controllers And/or Sensors. |
| Technical Method | The Device Facilitates Movement Of One Or Multiple Lower Extremity Joints (e.g. Hip, Knee, Ankle). |
| Target Area | The Device Is Intended To Be Used On The Lower Extremity. It May Be Used Unilaterally, Bilaterally, On A Single Joint, Or On Multiple Joints. |
| Regulation Description | Powered Lower Extremity Exoskeleton. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Neurology |
| 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) |
| CFR Regulation Number | 890.3480 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PHL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3824 |
| Device | Powered Exoskeleton |
| Product Code | PHL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Lower Extremity Exoskeleton. |
| CFR Regulation Number | 890.3480 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ARGO MEDICAL TECHNOLOGIES, INC. | ||
GRANTED | 1 | |
CYBERDYNE INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PARKER HANNIFIN CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Fracture | 6 |
Detachment Of Device Or Device Component | 5 |
Device Handling Problem | 2 |
Human-Device Interface Problem | 2 |
Component Missing | 1 |
Misassembly By Users | 1 |
Detachment Of Device Component | 1 |
Unintended Movement | 1 |
Crack | 1 |
| Total Device Problems | 20 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Argo Medical Technologies Ltd | II | Mar-09-2018 |