FDA product code ITW: Joint, Ankle, External Brace

ITW is the FDA product code for joint, ankle, external brace. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under ITW. The average 510(k) review took 8 days (median 8). FDA has posted 3 recalls for ITW devices.

Classification

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

Top ITW applicants

Most recent ITW clearances

Recalls for ITW devices

3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-02-24.

Frequently asked questions

What is FDA product code ITW?

ITW is the FDA product code for joint, ankle, external brace. It is a Class I device, regulated under 21 CFR 890.3475 and reviewed by the Physical Medicine panel.

What device class is ITW?

Class I, regulation 21 CFR 890.3475. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 8 days from receipt to decision (median 8).

Which companies have the most ITW clearances?

Fred Sammons, Inc. (1).

Have ITW devices been recalled?

Yes: 3 product recalls across 2 recall events; the most recent began 2016-02-24.

Next steps

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