IMJClass II
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
21 CFR 890.5290 / Physical Medicine
IMJ is the FDA product code for Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat, a class II device type, regulated under 21 CFR 890.5290. As of , FDA records hold 45 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- IMJ
- Device name
- Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- Regulation
- 21 CFR 890.5290
- Device class
- Class II
- Review panel
- Physical Medicine
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 45
- Ingested recalls
- 1
Clearances, product code IMJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 4 |
| 1984 | 2 |
| 1985 | 3 |
| 1986 | 9 |
| 1987 | 2 |
| 1995 | 1 |
| 1997 | 3 |
| 1998 | 1 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 1 |
| 2009 | 1 |
| 2012 | 1 |
| 2014 | 3 |
| 2016 | 3 |
| 2018 | 1 |
| 2019 | 1 |
| 2023 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Applicants with the most clearances
Product code IMJ| Applicant | Clearances |
|---|---|
| BTL Industries, Inc | 3 |
| Rich-Mar Corp. | 3 |
| Ehti Medical Corp. | 2 |
| General Theraphysical, Inc. | 2 |
| Henley Intl. | 2 |
| Intl. Medical Electronics, Ltd. | 2 |
| Mettler Electronics Corp | 2 |
| Nemectron Medical, Inc. | 2 |
| Selicor, Inc. | 2 |
| Viatherm Therapeutics, LLC | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
