FDA product code IMF: Unit, Chilling
IMF is the FDA product code for unit, chilling. It is a Class I device, regulated under 21 CFR 890.5940 and reviewed by the Physical Medicine panel. FDA has cleared 2 510(k) submissions under IMF. The average 510(k) review took 38 days (median 38). FDA has posted 1 recall for IMF devices.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Chilling |
| Device class | Class I |
| Regulation | 21 CFR 890.5940 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IMF clearance
Top IMF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Henley Intl. | 2 | 1990-02-27 |
Most recent IMF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900419 | Henley Intl. | CRYOTRON-UL30 | 1990-02-27 | 28 |
| K871112 | Henley Intl. | PELTIERTHERAPY(C) HEAT/COLD TREATMENT | 1987-05-06 | 48 |
Recalls for IMF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-06-25.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code IMF?
IMF is the FDA product code for unit, chilling. It is a Class I device, regulated under 21 CFR 890.5940 and reviewed by the Physical Medicine panel.
What device class is IMF?
Class I, regulation 21 CFR 890.5940. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IMF?
Across 2 cleared submissions the average was 38 days from receipt to decision (median 38).
Which companies have the most IMF clearances?
Henley Intl. (2).
Have IMF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-06-25.
Next steps
- Run an FDA pathway report with predicate devices for product code IMF
- Run a recall and safety report across every IMF manufacturer
- Watch product code IMF 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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