FDA product code IMI: Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
IMI is the FDA product code for ultrasonic diathermy for use in applying therapeutic deep heat. It is a Class II device, regulated under 21 CFR 890.5300 and reviewed by the Physical Medicine panel. FDA has cleared 89 510(k) submissions under IMI, 4 in the last five years, from 51 different applicants. The average 510(k) review took 156 days (median 121); 439 days on average over the last three years. FDA has posted 3 recalls for IMI devices.
Classification
| Field | Value |
|---|---|
| Device name | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Device class | Class II |
| Regulation | 21 CFR 890.5300 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for IMI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 562 |
| 2021 | 1 | 457 |
| 2022 | 1 | 448 |
| 2023 | 2 | 238 |
| 2025 | 1 | 439 |
Compare with all 510(k) review times · Search every IMI clearance
Top IMI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Metron Medical Australia, Pty, Ltd. | 9 | 2013-08-23 |
| Rich-Mar Corp. | 9 | 2002-09-13 |
| Mettler Electronics Corp. | 7 | 2006-05-04 |
| Chattanooga Group, Inc. | 7 | 1998-11-06 |
| General Project S.R.L. | 3 | 2016-08-16 |
46 more applicants have IMI clearances. See the full list in Caduvo.
Most recent IMI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240788 | Jkh Health Co., Ltd. | Ultrasound Stimulator | 2025-06-04 | 439 |
| K230472 | Enraf-Nonius, B.V. | Sonopuls 190 | 2023-10-24 | 244 |
| K222098 | Manamed, Inc. | ManaSport+ | 2023-03-08 | 233 |
| K210284 | Manamed, Inc. | ManaSport | 2022-04-26 | 448 |
| K202788 | Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto | Sonomed IV, Sonomed V | 2021-12-23 | 457 |
Recalls for IMI devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-02-28.
Frequently asked questions
What is FDA product code IMI?
IMI is the FDA product code for ultrasonic diathermy for use in applying therapeutic deep heat. It is a Class II device, regulated under 21 CFR 890.5300 and reviewed by the Physical Medicine panel.
What device class is IMI?
Class II, regulation 21 CFR 890.5300. Typical premarket route: 510(k).
How long does a 510(k) take for product code IMI?
Across 89 cleared submissions the average was 156 days from receipt to decision (median 121).
Which companies have the most IMI clearances?
Metron Medical Australia, Pty, Ltd. (9); Rich-Mar Corp. (9); Mettler Electronics Corp. (7); Chattanooga Group, Inc. (7); General Project S.R.L. (3).
Have IMI devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2008-02-28.
Next steps
- Run an FDA pathway report with predicate devices for product code IMI
- Run a recall and safety report across every IMI manufacturer
- Watch product code IMI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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