Data / Medical devices / China / Grandway Technology (shenzhen) Limited
Grandway Technology (shenzhen) Limited: FDA-registered device maker in Shenzhen Guangdong, China, 18 510(k) clearances
Grandway Technology (shenzhen) Limited is registered with the FDA (registration 3009155917) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 18 510(k) clearances under its listings, the newest dated July 22, 2019. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3009155917
- Address
- No. 5, the Second Industrial Zone, Zhukeng Community Longtian Street, Pingshan District, Shenzhen Guangdong, China, 518118
- Owner or operator
- Grandway Technology (Shenzhen) Limited (10036359)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 5, 2013
- Registered through
- 2027
- Brand names listed
- AFIB-4/0148, BM54, BP11G, Grandway - MD5681, MD1100, MD1110, MD1130, MD1150, MD1160, MD1180, MD1500, MD1520, MD1530, MD1560, MD1590, MD1800, MD1810, MD1820, MD1830, MD1840, MD1850, MD1860, MD1870, MD1801, MD1811, MD1821, MD1831, MD1841, MD1851, MD1861, MD1871 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Contract manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Contract manufacturer | accessdata.fda.gov |
| Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat | PFW | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | IMI | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 22, 2019 | K191593 | Digital Automatic Blood Pressure Monitor MD36 Series | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| April 10, 2018 | K171379 | Digital Automatic Wrist Blood Pressure Monitor MD4300 | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| July 7, 2017 | K163648 | Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| June 7, 2017 | K163679 | Digital Automatic Blood Pressure Monitor MD3600 | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| January 19, 2017 | K163113 | Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| September 29, 2015 | K152483 | Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| August 7, 2015 | K151587 | Digital Automatic Wrist Blood Pressure Monitor MD3200 | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| August 7, 2015 | K151583 | Digital Automatic Wrist Blood Pressure Monitor MD3900 | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| July 23, 2015 | K143735 | Digital Automatic Blood Pressure Monitor MD2300 | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| June 11, 2015 | K150373 | Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0] | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| May 2, 2015 | K143734 | Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810 | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| April 3, 2015 | K143733 | Digital Automatic Wrist Blood Pressure Monitor MD2400 | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| October 31, 2014 | K142088 | DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| June 18, 2014 | K140583 | DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM20 SERIES | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| March 5, 2014 | K133619 | DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| March 5, 2014 | K133618 | DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| February 14, 2013 | K120675 | DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
| February 14, 2013 | K120673 | DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES | DXN | Substantially Equivalent | Grandway Technology (Shenzhen) Limited | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- All makers of Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
- All makers of Sleeve, Limb, Compressible
- All makers of Massager, Therapeutic, Electric
- All makers of Massager, Powered Inflatable Tube
Updated July 22, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.