Data / Medical devices / Australia / GKC Manufacturing Pty Ltd
GKC Manufacturing Pty Ltd: FDA-registered device maker in Melbourne Victoria, Australia, 3 510(k) clearances
GKC Manufacturing Pty Ltd is registered with the FDA (registration 3011196543) in Melbourne Victoria, Australia. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 11, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011196543
- Address
- Level 9, 31 Queen Street, Melbourne Victoria, Australia, 3000
- Owner or operator
- Empatica S.r.l. (10047497)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- September 22, 2014
- Registered through
- 2026
- Brand names listed
- PKG, Personal KinetiGraph (PKG) System, Personal Kinetigraph System, Personal Kinetigraph System Gen 2 Plus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Exerciser, Measuring | ISD | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Reminder, Medication | NXQ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Transducer, Tremor | GYD | 2 | Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 11, 2022 | K211887 | Personal Kinetigraph (PKG) System Gen 2 Plus | GYD | Substantially Equivalent | Gkc Manufacturing Pty, Ltd. | accessdata.fda.gov |
| September 20, 2016 | K161717 | Personal Kinetigraph (PKG) System | GYD | Substantially Equivalent | Gkc Manufacturing Pty, Ltd. | accessdata.fda.gov |
| August 22, 2014 | K140086 | PERSONAL KINETIGRAPH (PKG) SYSTEM | GYD | Substantially Equivalent | Gkc Manufacturing Pty, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Reminder, Medication
- All makers of Transducer, Tremor
- All makers of Exerciser, Measuring
Updated March 11, 2022. 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.