GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3009155917

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
3009155917
FEI Number
3009155917
Entity Name
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
No. 5, the Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District, Shenzhen Guangdong 518118, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Grandway Technology (Shenzhen) Limited (Owner Number: 10036359)
Owner / Operator Contact Address
No. 5, the Second Industrial Zone, Zhukeng Community, Longtian Street, Pingshan District, Shenzhen, CN-GD 518118, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K163113
PMA Number
N/A

All Registered Proprietary Names

MD2220, MD2222, MD2223, MD2230, MD2231, MD2232 MD2200 MD2210 Grandway - MD5681 MD5990 MD5940 MD6290 MD5960 BP11G MD5451 BM54 MD41A0 MD6300 MD47A1 AFIB-4/0148 MD1801, MD1811, MD1821, MD1831, MD1841, MD1851, MD1861, MD1871 MD1800, MD1810, MD1820, MD1830, MD1840, MD1850, MD1860, MD1870 MD1500, MD1520, MD1530, MD1560, MD1590

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2025-09-28
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-12-07
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2014-03-20
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2019-04-15
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2024-07-18
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-08-11
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-06-08
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-08-11
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-06-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2014-11-04
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-09-01
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2019-07-30
IRP Massager, Powered Inflatable Tube Physical Medicine Class 2 890.5650 2025-07-09
PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5300 2025-09-28
IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5300 2025-09-28
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2014-06-18
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-10-18
JOW Sleeve, Limb, Compressible Cardiovascular Class 2 870.5800 2024-09-25
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2015-06-12
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2014-03-20
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2013-11-05
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2017-01-19

Official Correspondent

Patrick Chow

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Grandway Technology (Shenzhen) Limited
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
K170216 Tactile Systems Technology, Inc. (Dba Tactile Medical) Flexitouch System 2017-05-26
K100306 Covidien KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES 2010-05-04
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

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 3009155917. Last updated year: 2026. Please use registration number 3009155917 when referencing this establishment in official correspondence.
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