FDA product code IMA: Pack, Heat, Moist
IMA is the FDA product code for pack, heat, moist. It is a Class I device, regulated under 21 CFR 890.5730 and reviewed by the Physical Medicine panel. FDA has cleared 8 510(k) submissions under IMA, from 8 different applicants. The average 510(k) review took 35 days (median 24). FDA has posted 9 recalls for IMA devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pack, Heat, Moist |
| Device class | Class I |
| Regulation | 21 CFR 890.5730 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IMA clearance
Top IMA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rachel'S Remedies, LLC | 1 | 2015-05-22 |
| Wahl Clipper Corp. | 1 | 1995-03-24 |
| Maddak, Inc. | 1 | 1984-05-10 |
| Electro-Med Health Industries, Inc. | 1 | 1983-09-20 |
| Fred Sammons, Inc. | 1 | 1982-12-30 |
3 more applicants have IMA clearances. See the full list in Caduvo.
Most recent IMA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150139 | Rachel'S Remedies, LLC | Rachel's Remedy | 2015-05-22 | 120 |
| K950701 | Wahl Clipper Corp. | WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER | 1995-03-24 | 37 |
| K841698 | Maddak, Inc. | HEAT PACK | 1984-05-10 | 17 |
| K832803 | Electro-Med Health Industries, Inc. | STEAM PAK MOIST HEAT | 1983-09-20 | 33 |
| K823622 | Fred Sammons, Inc. | INSULATED THERMOELASTOMER MITT | 1982-12-30 | 24 |
Recalls for IMA devices
9 product recalls in 1 recall events; 9 initiated in the last five years and 9 still open. Most recent: 2024-02-21.
| Year | Recalls |
|---|---|
| 2024 | 9 |
Frequently asked questions
What is FDA product code IMA?
IMA is the FDA product code for pack, heat, moist. It is a Class I device, regulated under 21 CFR 890.5730 and reviewed by the Physical Medicine panel.
What device class is IMA?
Class I, regulation 21 CFR 890.5730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IMA?
Across 8 cleared submissions the average was 35 days from receipt to decision (median 24).
Which companies have the most IMA clearances?
Rachel'S Remedies, LLC (1); Wahl Clipper Corp. (1); Maddak, Inc. (1); Electro-Med Health Industries, Inc. (1); Fred Sammons, Inc. (1).
Have IMA devices been recalled?
Yes: 9 product recalls across 1 recall events; the most recent began 2024-02-21.
Next steps
- Run an FDA pathway report with predicate devices for product code IMA
- Run a recall and safety report across every IMA manufacturer
- Watch product code IMA 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.
All Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times