Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018159965

FEI Number

3018159965

Entity Name

IMANI

City/State/Country

Yongin Gyeonggi, KR

Establishment Address

147, Hwasan-ro, Idong-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea., Yongin Gyeonggi 17135, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

imani (Owner Number: 10080975)

Owner / Operator Contact Address

147, Hwasan-ro, Idong-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of Korea., Yongin, KR-41 17135, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202045

PMA Number

N/A

All Registered Proprietary Names

imani i2Plus, imani i2Plus Pro imani i1, imani i1Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2023-03-06
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2021-03-09

Official Correspondent

Hwang Hyosoon

US Agent Details

Jonathan C Gillan Business: Milk Matters Collective LLC Email: jon@pumpinpal.com Phone: (602) 3901596

Related Public Records

Same Entity

imani

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190465	Hygeia II Medical Group, Inc.	Evolve Breast Pump	2019-10-18
K021739	Limerick, Inc.	LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002	2003-01-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018159965. Last updated year: 2026. Please use registration number 3018159965 when referencing this establishment in official correspondence.