Data / Medical devices / Hong Kong / Porticos Asia Limited
Porticos Asia Limited: FDA-registered device maker in Hong Kong, Hong Kong, 1 510(k) clearance
Porticos Asia Limited is registered with the FDA (registration 3021988268) in Hong Kong, Hong Kong. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 21, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021988268
- Address
- Unit 1916, 19/F Shatin Galleria, 18-24 Shan Mei Street, Fo Tan, Hong Kong, Hong Kong, 00000
- Owner or operator
- Porticos Asia Limited (10090055)
- Roles
- Exporter to the US
- First device listed
- February 8, 2024
- Registered through
- 2026
- Brand names listed
- Telepatch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | 2 | Exporter to the US | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Exporter to the US | 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 21, 2016 | K161916 | TelePatch Cardiac Monitor | DRG | Substantially Equivalent | Medicomp, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Electrocardiograph, Ambulatory, With Analysis Algorithm
Updated December 21, 2016. 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.