CSA SERVICE SOLUTIONS, LLC

FDA Device Registration & Listing · Wilmington, OH, US · Registration 3015522053

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
3015522053
FEI Number
3015522053
Entity Name
CSA SERVICE SOLUTIONS, LLC
City/State/Country
Wilmington, OH, US
Establishment Address
270 Davids Drive, Wilmington, OH 45177, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
EMSAR (Owner Number: 10043998)
Owner / Operator Contact Address
270 Davids Drive, Wilmington, OH 45177, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Higi Health Station Higi Health Station Higi Health Station Higi Health Station Higi Health Station Higi Health Station

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-10-27
MNW Analyzer, Body Composition Cardiovascular Class 2 870.2770 2021-10-27
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2021-10-27
MNW Analyzer, Body Composition Cardiovascular Class 2 870.2770 2021-10-27
HIT Tester, Color Vision Ophthalmic Class 1 886.1170 2015-01-15
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-01-15
MNW Analyzer, Body Composition Cardiovascular Class 2 870.2770 2015-01-15
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2013-04-16

Official Correspondent

Kimberly Martinez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EMSAR
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
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
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

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 3015522053. Last updated year: 2026. Please use registration number 3015522053 when referencing this establishment in official correspondence.
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