FDA product code IRS: Head Halter, Traction
IRS is the FDA product code for head halter, traction. It is a Class I device, regulated under 21 CFR 890.5925 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under IRS. The average 510(k) review took 83 days (median 83).
Classification
| Field | Value |
|---|---|
| Device name | Head Halter, Traction |
| Device class | Class I |
| Regulation | 21 CFR 890.5925 |
| 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 IRS clearance
Top IRS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chattanooga Pharmacal Co. | 1 | 1977-07-11 |
Most recent IRS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K770724 | Chattanooga Pharmacal Co. | TRACTION DEVICES, INTERMITTENT, TX | 1977-07-11 | 83 |
Recalls for IRS devices
openFDA lists no recalls for product code IRS.
Frequently asked questions
What is FDA product code IRS?
IRS is the FDA product code for head halter, traction. It is a Class I device, regulated under 21 CFR 890.5925 and reviewed by the Physical Medicine panel.
What device class is IRS?
Class I, regulation 21 CFR 890.5925. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IRS?
Across 1 cleared submissions the average was 83 days from receipt to decision (median 83).
Which companies have the most IRS clearances?
Chattanooga Pharmacal Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IRS
- Run a recall and safety report across every IRS manufacturer
- Watch product code IRS 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