HIGI SH LLC

FDA Device Registration & Listing · Chicago, IL, US · Registration 3003703880

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
3003703880
FEI Number
3003703880
Entity Name
HIGI SH LLC
City/State/Country
Chicago, IL, US
Establishment Address
20 N Wacker Dr Ste 1642, Chicago, IL 60606, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
higi SH LLC (Owner Number: 10032072)
Owner / Operator Contact Address
20 N. Wacker Drive, Suite 1642, Chicago, IL 60606, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K123539
PMA Number
N/A

All Registered Proprietary Names

BC4 Body Composition Analyzer higi station HIGI Kiosk HIGI Station higi Station Analyzer Body Composition Stayhealthy HealthCENTER Kiosk Stayhealthy Health Kiosk

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MNW Analyzer, Body Composition Cardiovascular Class 2 870.2770 2014-12-03
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-11-29
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2014-12-03
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-12-21
MNW Analyzer, Body Composition Cardiovascular Class 2 870.2770 2010-04-06
MNW Analyzer, Body Composition Cardiovascular Class 2 870.2770 2013-11-21
HIT Tester, Color Vision Ophthalmic Class 1 886.1170 2013-11-21
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2013-11-21

Official Correspondent

Amy Halik

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

higi SH LLC
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
K994242 Bodystat , Ltd. BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT 2000-03-15
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003703880. Last updated year: 2026. Please use registration number 3003703880 when referencing this establishment in official correspondence.
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