FDA product code IRQ: Unit, Heating, Powered
IRQ is the FDA product code for unit, heating, powered. It is a Class I device, regulated under 21 CFR 890.5950 and reviewed by the Physical Medicine panel. FDA has cleared 7 510(k) submissions under IRQ, from 7 different applicants. The average 510(k) review took 110 days (median 80). FDA has posted 1 recall for IRQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Heating, Powered |
| Device class | Class I |
| Regulation | 21 CFR 890.5950 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IRQ clearance
Top IRQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Marda Medical, Inc. | 1 | 2005-09-14 |
| Whitehall/Div Columbus Mckennon Corp. | 1 | 1995-03-24 |
| Ferno | 1 | 1993-04-14 |
| Fred Sammons, Inc. | 1 | 1988-05-06 |
| Tri W-G, Inc. | 1 | 1986-05-02 |
2 more applicants have IRQ clearances. See the full list in Caduvo.
Most recent IRQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K050524 | Marda Medical, Inc. | EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 | 2005-09-14 | 196 |
| K950350 | Whitehall/Div Columbus Mckennon Corp. | THEMALATOR. MODELS T-4-S, T-8-S, ETC. | 1995-03-24 | 53 |
| K924023 | Ferno | FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 | 1993-04-14 | 246 |
| K880644 | Fred Sammons, Inc. | ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) | 1988-05-06 | 80 |
| K861340 | Tri W-G, Inc. | R1750 AND R1424 POWERED HEATING UNITS | 1986-05-02 | 25 |
Recalls for IRQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-11-15.
Frequently asked questions
What is FDA product code IRQ?
IRQ is the FDA product code for unit, heating, powered. It is a Class I device, regulated under 21 CFR 890.5950 and reviewed by the Physical Medicine panel.
What device class is IRQ?
Class I, regulation 21 CFR 890.5950. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IRQ?
Across 7 cleared submissions the average was 110 days from receipt to decision (median 80).
Which companies have the most IRQ clearances?
Marda Medical, Inc. (1); Whitehall/Div Columbus Mckennon Corp. (1); Ferno (1); Fred Sammons, Inc. (1); Tri W-G, Inc. (1).
Have IRQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-11-15.
Next steps
- Run an FDA pathway report with predicate devices for product code IRQ
- Run a recall and safety report across every IRQ manufacturer
- Watch product code IRQ 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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