FDA product code LFF: Unit, Activation, Breath Control

LFF is the FDA product code for unit, activation, breath control. It is a Class I device, regulated under 21 CFR 890.3920 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under LFF. The average 510(k) review took 627 days (median 627).

Classification

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

Top LFF applicants

Most recent LFF clearances

Recalls for LFF devices

openFDA lists no recalls for product code LFF.

Frequently asked questions

What is FDA product code LFF?

LFF is the FDA product code for unit, activation, breath control. It is a Class I device, regulated under 21 CFR 890.3920 and reviewed by the Physical Medicine panel.

What device class is LFF?

Class I, regulation 21 CFR 890.3920. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 627 days from receipt to decision (median 627).

Which companies have the most LFF clearances?

Interactive Living Systems, Inc. (1).

Next steps

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