| Device Type ID | 5091 |
| Device Name | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Regulation Description | Ultrasound And Muscle Stimulator. |
| 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) |
| CFR Regulation Number | 890.5860 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | IMG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 5091 |
| Device | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Product Code | IMG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ultrasound And Muscle Stimulator. |
| CFR Regulation Number | 890.5860 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACCELERATED CARE PLUS (ACP) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BTL INDUSTRIES LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 7 |
Degraded | 1 |
Physical Property Issue | 1 |
Material Integrity Problem | 1 |
Temperature Problem | 1 |
| Total Device Problems | 11 |