SUNTECH MEDICAL, INC.

FDA Device Registration & Listing · MORRISVILLE, NC, US · Registration 1036863

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
1036863
FEI Number
1036863
Entity Name
SUNTECH MEDICAL, INC.
City/State/Country
MORRISVILLE, NC, US
Establishment Address
5827 S. Miami Boulevard, Suite 100, MORRISVILLE, NC 27560, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SUNTECH MEDICAL, INC. (Owner Number: 1036863)
Owner / Operator Contact Address
5827 S. Miami Boulevard, Suite 100, Morrisville, NC 27560, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K080854
PMA Number
N/A

All Registered Proprietary Names

SunTech Oscar 2, 24-HR ABPM Oscar 2, Model 250 ALL PURPOSE CUFF Disposable Cuff

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 2016-02-21
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2006-12-07
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2008-10-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SUNTECH MEDICAL, INC.
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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3036999955 ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL Largo, MD, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1036863. Last updated year: 2026. Please use registration number 1036863 when referencing this establishment in official correspondence.
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