FDA product code IQX: Hook, External Limb Component, Mechanical

IQX is the FDA product code for hook, external limb component, mechanical. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under IQX. The average 510(k) review took 13 days (median 13).

Classification

Compare with all 510(k) review times · Search every IQX clearance

Top IQX applicants

Most recent IQX clearances

Recalls for IQX devices

openFDA lists no recalls for product code IQX.

Frequently asked questions

What is FDA product code IQX?

IQX is the FDA product code for hook, external limb component, mechanical. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel.

What device class is IQX?

Class I, regulation 21 CFR 890.3420. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code IQX?

Across 1 cleared submissions the average was 13 days from receipt to decision (median 13).

Which companies have the most IQX clearances?

Hosmer Dorrance Corp. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code IQX
• Run a recall and safety report across every IQX manufacturer
• Watch product code IQX 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