Definition: Ultrasonic Diathermy Devices Which Include Stationary Applicators Enabling Hands-free Operation.
| Device Type ID | 5240 |
| Device Name | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Physical State | Ultrasonic Diathermy Devices Which Include Stationary Applicators Enabling Hands-free Operation. |
| Technical Method | The Device Uses Ultrasonic Energy To Produce Deep Heat Within The Body. |
| Target Area | To Be Applied Over Body Areas Such As The Shoulder And Knee; However, The Device Should Not Be Applied Directly Over Bone That Is Near The Skin Surface. |
| Regulation Description | Ultrasonic Diathermy. |
| 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 | 890.5300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PFW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 5240 |
| Device | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Product Code | PFW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ultrasonic Diathermy. |
| CFR Regulation Number | 890.5300 [🔎] |