Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1054421

FEI Number

1000110823

Entity Name

A&D Engineering, Inc.

City/State/Country

Duluth, GA, US

Establishment Address

2605 N.Berkeley Lake Rd., Bldg 100, ste 350, Duluth, GA 30096, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

A&D Company, Limited (Owner Number: 8031633)

Owner / Operator Contact Address

3-23-14 HIGASHI-IKEBUKURO, TOSHIMA-KU, JP-13 170-0013, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212168

PMA Number

N/A

All Registered Proprietary Names

TM-CF602D TM-2440 & TM-2441 TM-CF702D UltraConnect UA-1200BLE Blood Pressure Monitor UA-1200CNBLE UA-789AC DT-102 DT-103 A&D Medical UM-211 Digital Blood Pressure Monitor A&D Medical UB-543 UA-660 UA-651M-AC UA-651W-AC UA-651 UA-651S-AC UA-651L-AC UA-611 UA-660CN UB-525 Digital Blood Pressure Monitor DT-105 Thermometer UltraConnect UB-1100BLE Blood Pressure Monitor UA-767PVS UA-767Plus UA-787EJ UA-611 UA-787 UA-767PSAC UA-1030T UA-1020 UC-355PBT-Ci UC-352BLE-V UC-350BLE UC-351 UC-352BLE UC-321PBT-Q UC-351PBT-Ci UC-356BLE UC-356BLE-ST UM-SARS4K1KEC UM-AURS2M1KEC UM-SARS2M1KEC UM-212BLE Blood Pressure Monitor UM-AURS4K1KEC UM-SSRS2M1KEC UM-LLRS4K1KEC UM-LARS4K1KEC UM-LARS2M1KEC UM-SSRS4K1KEC UM-LLRS2M1KEC

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	2019-06-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-08-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-01-03
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2014-01-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-03-27
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-01-26
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-10-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2005-09-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2019-10-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-08-11
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-05-29
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2011-12-07
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2020-02-03
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-12-27
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2022-12-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

A&D Company, Limited

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012935929	A&D SCALES CO., LTD.	Jincheon-gun Chungbuk, KR
3006899423	A&D Manufacturing Company, Limited - Tsukuba Factory	Shimotsuma-shi Ibaraki, JP
3013920399	A&D Vietnam Limited	Tu Son Ward Bac Ninh, VN
2082313	A&D ENGINEERING, INC.	Ann Arbor, MI, US
3004128050	A&D Electronics (Shenzhen) Co., Ltd.	Shenzhen Guangdong, CN

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 1054421. Last updated year: 2026. Please use registration number 1054421 when referencing this establishment in official correspondence.