Data / Medical devices / United States / Harvest Bio LLC
Harvest Bio LLC: FDA-registered device maker in Middletown, CT, United States, 2 510(k) clearances
Harvest Bio LLC is registered with the FDA (registration 3033280591) in Middletown, CT, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 10, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033280591
- Address
- 101 Centerpoint Dr Ste 105, Middletown, CT, United States, 06457
- Owner or operator
- Harvest Bio (10091901)
- Roles
- Manufacturer
- First device listed
- November 14, 2024
- Registered through
- 2026
- Brand names listed
- RESET, RESET-O
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computerized Behavioral Therapy Device For Substance Use Disorders | PWE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 10, 2018 | K173681 | reSET-O | PWE | Substantially Equivalent | Pear Therapeutics, Inc. | accessdata.fda.gov |
| September 14, 2017 | DEN160018 | reSet | PWE | Unknown | Pear Therapeutics, Inc. | accessdata.fda.gov |
Updated December 10, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.