Chrysalis Intelligence · Sponsors · Pear Therapeutics, Inc.

Pear Therapeutics, Inc.

San Francisco, CA, US · 1 510(k) clearances · 2 recalls

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Total clearances
1
2020-03-23 → 2020-03-23
Last 12 months
0
Product codes
1
Most recent
2020-03-23
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QVO Computerized Behavioral Therapy Device For Insomnia Class II Neurology 1 2020-03-23
Safety

Recalls (2)

Class I (serious)
0
Risk of injury / death
Total recalls
2
Currently ongoing
0
Most recent
2021-06-07
DateSeverityStatusRecall # ProductCodeReason
2021-06-07 Class II Terminated Z-1926-2021 reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment. — Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the …
2021-06-07 Class II Terminated Z-1925-2021 reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment. — Due to a software issue, patients with a urine drug screen (UDS) received access to a contingency management wheel spin for potential rewards regardless of the …
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2020-03-23 K191716 Somryst QVO Class II Neurology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence