| Device Type ID | 5093 |
| Device Name | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| 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 | IMJ |
| 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 | 5093 |
| Device | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Product Code | IMJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Shortwave Diathermy. |
| CFR Regulation Number | 890.5290 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACCELERATED CARE PLUS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IBRAMED EQUIPAMENTOS MEDICOS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCKY MOUNTAIN BIOSYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER ELEKTROMEDIZIN GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Loose Or Intermittent Connection | 1 |
Device Inoperable | 1 |
Fire | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | DJO, LLC | II | Oct-15-2015 |