FDA product code IRR: Bars, Parallel, Powered
IRR is the FDA product code for bars, parallel, powered. It is a Class I device, regulated under 21 CFR 890.5380 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under IRR. The average 510(k) review took 329 days (median 329).
Classification
| Field | Value |
|---|---|
| Device name | Bars, Parallel, Powered |
| Device class | Class I |
| Regulation | 21 CFR 890.5380 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IRR clearance
Top IRR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bailey Mfg. Co. | 1 | 1994-04-01 |
Most recent IRR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932240 | Bailey Mfg. Co. | MODEL 5200-10,5200-12 HI-LOW ELEC. PARRALLEL BARS | 1994-04-01 | 329 |
Recalls for IRR devices
openFDA lists no recalls for product code IRR.
Frequently asked questions
What is FDA product code IRR?
IRR is the FDA product code for bars, parallel, powered. It is a Class I device, regulated under 21 CFR 890.5380 and reviewed by the Physical Medicine panel.
What device class is IRR?
Class I, regulation 21 CFR 890.5380. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IRR?
Across 1 cleared submissions the average was 329 days from receipt to decision (median 329).
Which companies have the most IRR clearances?
Bailey Mfg. Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IRR
- Run a recall and safety report across every IRR manufacturer
- Watch product code IRR 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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