reSET-O— 510(k) K173681

Substantially Equivalent

Pear Therapeutics, Inc.

FDA 510(k) clearance K173681 for reSET-O, Substantially Equivalent on 2018-12-10. Applicant: Pear Therapeutics, Inc.. Device class: 2.

Clearance details

Applicant: Pear Therapeutics, Inc.
Product code: Code PWE
Device class: Class 2
Regulation: 21 CFR 882.5801
Advisory panel: Neurology
Date received: 2017-12-01
Decision date: 2018-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PWE

DEN160018 — reSet2017-09-14

More clearances from Pear Therapeutics, Inc.

K191716 — Somryst2020-03-23

Recalls naming K173681

K-number listed on FDA's recall record

Z-1925-2021 — reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.Class II·Terminated·Pear Therapeutics, Inc.·20210607
Z-1926-2021 — reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.Class II·Terminated·Pear Therapeutics, Inc.·20210607

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173681.

Data sourced from openFDA. This site is unofficial and independent of the FDA.