Definition: Nonthermal Pulsed Electromagnetic Energy Intended For Over-the-counter Use For The Treatment Of Pain.
| Device Type ID | 5244 |
| Device Name | Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain |
| Physical State | Nonthermal Shortwave Therapy Devices Which Include Applicators Applied To The Body. |
| Technical Method | Uses Pulsed Electromagnetic Energy At 13.56 MHz Or 27.12 MHz Delivered Treatment. |
| Target Area | To Be Applied Over Body Areas And Joints Such As The Knee And Ankle; However, The Device Should Not Be Applied Directly Over Areas With Active Implantables. |
| Regulation Description | Shortwave 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 | 890.5290 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PQY |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5244 |
| Device | Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain |
| Product Code | PQY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Shortwave Diathermy. |
| CFR Regulation Number | 890.5290 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOELECTRONICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |