Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010447004

FEI Number

3010447004

Entity Name

Otsuka Precision Health, Inc.

City/State/Country

Princeton, NJ, US

Establishment Address

508 Carnegie Ctr, Princeton, NJ 08540, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Otsuka Precision Health, Inc. (Owner Number: 10094881)

Owner / Operator Contact Address

508 CARNEGIE CENTER DRIVE, Princeton, NJ 08540, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231209

PMA Number

N/A

All Registered Proprietary Names

Rejoyn

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SAP	Computerized Behavioral Therapy Device For Depressive Disorders.	Neurology	Class 2	882.5801	2025-12-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Otsuka Precision Health, Inc.

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 3010447004. Last updated year: 2026. Please use registration number 3010447004 when referencing this establishment in official correspondence.