FDA product code IMB: Cabinet, Moist Steam
IMB is the FDA product code for cabinet, moist steam. It is a Class II device, regulated under 21 CFR 890.5250 and reviewed by the Physical Medicine panel. FDA has cleared 5 510(k) submissions under IMB, from 5 different applicants. The average 510(k) review took 286 days (median 144). FDA has posted 5 recalls for IMB devices.
Classification
| Field | Value |
|---|---|
| Device name | Cabinet, Moist Steam |
| Device class | Class II |
| Regulation | 21 CFR 890.5250 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IMB clearance
Top IMB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Scandia Manufacturing , Ltd. | 1 | 2002-04-15 |
| Thermia, Inc. | 1 | 1997-11-03 |
| Sauna Magic, Inc. | 1 | 1992-02-11 |
| Shinsei Corp. | 1 | 1981-03-04 |
| Health Improvement Assoc. | 1 | 1977-04-18 |
Most recent IMB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K003916 | Scandia Manufacturing , Ltd. | DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM | 2002-04-15 | 482 |
| K955808 | Thermia, Inc. | DYNA T-2000 PHYSICAL THERAPY SYSTEM | 1997-11-03 | 682 |
| K914234 | Sauna Magic, Inc. | SAUNETTE, PORTABLE STEAM CABIN | 1992-02-11 | 144 |
| K810320 | Shinsei Corp. | HEATPAC | 1981-03-04 | 26 |
| K770086 | Health Improvement Assoc. | SANAR | 1977-04-18 | 94 |
Recalls for IMB devices
5 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-06-22.
Frequently asked questions
What is FDA product code IMB?
IMB is the FDA product code for cabinet, moist steam. It is a Class II device, regulated under 21 CFR 890.5250 and reviewed by the Physical Medicine panel.
What device class is IMB?
Class II, regulation 21 CFR 890.5250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IMB?
Across 5 cleared submissions the average was 286 days from receipt to decision (median 144).
Which companies have the most IMB clearances?
Scandia Manufacturing , Ltd. (1); Thermia, Inc. (1); Sauna Magic, Inc. (1); Shinsei Corp. (1); Health Improvement Assoc. (1).
Have IMB devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2007-06-22.
Next steps
- Run an FDA pathway report with predicate devices for product code IMB
- Run a recall and safety report across every IMB manufacturer
- Watch product code IMB 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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