HARVEST BIO LLC

FDA Device Registration & Listing · Middletown, CT, US · Registration 3033280591

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3033280591
FEI Number
3033280591
Entity Name
HARVEST BIO LLC
City/State/Country
Middletown, CT, US
Establishment Address
101 Centerpoint Dr Ste 105, Middletown, CT 06457, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Harvest Bio (Owner Number: 10091901)
Owner / Operator Contact Address
101 Centerpoint Drive - Ste 105, Middletown, CT 06457, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K173681
PMA Number
N/A

All Registered Proprietary Names

RESET-O

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PWE Computerized Behavioral Therapy Device For Substance Use Disorders Neurology Class 2 882.5801 2024-11-14

Official Correspondent

Tyler Countie

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Harvest Bio
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033280591. Last updated year: 2026. Please use registration number 3033280591 when referencing this establishment in official correspondence.
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