FDA product code PWE: Computerized Behavioral Therapy Device For Substance Use Disorders

PWE is the FDA product code for computerized behavioral therapy device for substance use disorders. It is a Class II device, regulated under 21 CFR 882.5801 and reviewed by the Neurology panel. FDA has cleared 1 510(k) submission under PWE. The average 510(k) review took 374 days (median 374). 1 De Novo request was granted under it. FDA has posted 2 recalls for PWE devices.

Definition

The device is intended to provide cognitive behavioral therapy to treat substance use disorder.

Classification

510(k) clearances per year for PWE

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

Top PWE applicants

Most recent PWE clearances

Recalls for PWE devices

2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-06-07.

Frequently asked questions

What is FDA product code PWE?

PWE is the FDA product code for computerized behavioral therapy device for substance use disorders. It is a Class II device, regulated under 21 CFR 882.5801 and reviewed by the Neurology panel.

What device class is PWE?

Class II, regulation 21 CFR 882.5801. Typical premarket route: 510(k).

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

Across 1 cleared submissions the average was 374 days from receipt to decision (median 374).

Which companies have the most PWE clearances?

Pear Therapeutics, Inc. (1).

Have PWE devices been recalled?

Yes: 2 product recalls across 1 recall events; the most recent began 2021-06-07.

Next steps

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