FDA product code ISW: Assembly, Knee/Shank/Ankle/Foot, External

ISW is the FDA product code for assembly, knee/shank/ankle/foot, external. It is a Class II device, regulated under 21 CFR 890.3500 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under ISW. The average 510(k) review took 62 days (median 62). FDA has posted 10 recalls for ISW devices, 6 initiated in the last five years.

Classification

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

Top ISW applicants

Most recent ISW clearances

Recalls for ISW devices

10 product recalls in 7 recall events; 6 initiated in the last five years and 6 still open. Most recent: 2024-03-25.

Frequently asked questions

What is FDA product code ISW?

ISW is the FDA product code for assembly, knee/shank/ankle/foot, external. It is a Class II device, regulated under 21 CFR 890.3500 and reviewed by the Physical Medicine panel.

What device class is ISW?

Class II, regulation 21 CFR 890.3500. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 62 days from receipt to decision (median 62).

Which companies have the most ISW clearances?

Otto Bock Orthopedic Industry, Inc. (1).

Have ISW devices been recalled?

Yes: 10 product recalls across 7 recall events; the most recent began 2024-03-25.

Next steps

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