FDA product code IMG: Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
IMG is the FDA product code for stimulator, ultrasound and muscle, for use in applying therapeutic deep heat. It is a Class II device, regulated under 21 CFR 890.5860 and reviewed by the Physical Medicine panel. FDA has cleared 55 510(k) submissions under IMG, 1 in the last five years, from 25 different applicants. The average 510(k) review took 151 days (median 105); 281 days on average over the last three years. FDA has posted 2 recalls for IMG devices.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Device class | Class II |
| Regulation | 21 CFR 890.5860 |
| 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 IMG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 281 |
Compare with all 510(k) review times · Search every IMG clearance
Top IMG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chattanooga Group, Inc. | 11 | 1999-02-01 |
| Mettler Electronics Corp. | 6 | 2011-08-25 |
| Rich-Mar Corp. | 5 | 1992-11-06 |
| Shenzhen Dongdixin Technology Co., Ltd. | 3 | 2015-11-13 |
| Excel Tech. , Ltd. | 3 | 2000-07-07 |
20 more applicants have IMG clearances. See the full list in Caduvo.
Most recent IMG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K244041 | Xemis Medical Technology (Shenzhen) Co., Ltd. | Ultrasound Therapy Workstation (XMS-UET2) | 2025-10-07 | 281 |
| K153559 | Accelerated Care Plus (Acp) | OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System | 2016-08-26 | 256 |
| K150436 | Shenzhen Dongdixin Technology Co., Ltd. | ComboRehab | 2015-11-13 | 267 |
| K150353 | BTL Industries, Inc. | BTL-4000 | 2015-11-13 | 275 |
| K120217 | Shenzhen Dongdixin Technology Co., Ltd. | SONICSTIMU COMBO THERAPEUTIC DEVICE | 2012-11-21 | 302 |
Recalls for IMG devices
2 product recalls in 1 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 IMG?
IMG is the FDA product code for stimulator, ultrasound and muscle, for use in applying therapeutic deep heat. It is a Class II device, regulated under 21 CFR 890.5860 and reviewed by the Physical Medicine panel.
What device class is IMG?
Class II, regulation 21 CFR 890.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code IMG?
Across 55 cleared submissions the average was 151 days from receipt to decision (median 105).
Which companies have the most IMG clearances?
Chattanooga Group, Inc. (11); Mettler Electronics Corp. (6); Rich-Mar Corp. (5); Shenzhen Dongdixin Technology Co., Ltd. (3); Excel Tech. , Ltd. (3).
Have IMG devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2008-02-28.
Next steps
- Run an FDA pathway report with predicate devices for product code IMG
- Run a recall and safety report across every IMG manufacturer
- Watch product code IMG 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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