Data / Medical devices / Hong Kong / Truly Instrument Limited
Truly Instrument Limited: FDA-registered device maker in Kwai Chung, Hong Kong, 10 510(k) clearances
Truly Instrument Limited is registered with the FDA (registration 3003657019) in Kwai Chung, Hong Kong. It lists 3 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 23, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003657019
- Address
- 2ND Floor, 1-3 Wing Yip ST., Kwai Chung, Hong Kong, --
- Owner or operator
- TRULY INSTRUMENT LIMITED (9054344)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- December 18, 2002
- Registered through
- 2026
- Brand names listed
- Andesfit Limited, Blood Pressure Monitor, Infopia Automatic Blood Pressure Monitor, Masters, PressurePlus Automatic Blood Pressure Monitor, ReliaMed, SAMICO, SmartDiabetes Automatic Blood Pressure Monitor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Contract manufacturer, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Toothbrush, Ionic, Battery-Powered | MMD | 1 | 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 |
|---|---|---|---|---|---|---|
| December 23, 2019 | K192023 | Arm Blood Pressure Monitor | DXN | Substantially Equivalent | Truly Instrument Limited | accessdata.fda.gov |
| November 21, 2017 | K170545 | Automatic Wrist Bluetooth Blood Pressure Monitor | DXN | Substantially Equivalent | Truly Instrument , Ltd. | accessdata.fda.gov |
| October 24, 2016 | K161846 | Automatic Arm Bluetooth Blood Pressure Monitor | DXN | Substantially Equivalent | Truly Instrument Limited | accessdata.fda.gov |
| January 19, 2012 | K113083 | TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Truly Instrument Co., Ltd. | accessdata.fda.gov |
| January 12, 2012 | K113085 | TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Truly Instrument Co., Ltd. | accessdata.fda.gov |
| September 4, 2009 | K091434 | TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M | DXN | Substantially Equivalent | Truly Instrument Co., Ltd. | accessdata.fda.gov |
| September 4, 2009 | K091415 | TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M | DXN | Substantially Equivalent | Truly Instrument Co., Ltd. | accessdata.fda.gov |
| June 24, 2009 | K090564 | TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 | FLL | Substantially Equivalent | Truly Instrument Limited | accessdata.fda.gov |
| December 12, 2008 | K081852 | TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11 | DXN | Substantially Equivalent | Truly Instrument Limited | accessdata.fda.gov |
| September 13, 2002 | K014141 | DIGIBIO DIGTIAL BLOOD PRESSURE MONITOR MODEL D11 | DXN | Substantially Equivalent | Digibio Technology Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Toothbrush, Ionic, Battery-Powered
- All makers of Continuous Measurement Thermometer
Updated December 23, 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.