510(k) K161717
- Device
- Personal Kinetigraph (PKG) System
- Applicant
- GKC MANUFACTURING PTY LTD.
- 510(k) number
- K161717
- Product code
- GYD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-09-20
- Date received
- 2016-06-22
- Regulation
- 882.1950
- Classification name
- Transducer, Tremor
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRENDAN FAFIANI
- Address
- Level 15, 440 Collins St. Melbourne AU 3000 3000
FDA Registration Numbers#
- 3032027298
- 3011196543
- 3009134706
- 3012933969
Source Documents#
Other 510(k) Records For Product Code GYD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250153 | Neu Platform | Neuhealth Digital , Ltd. | 2025-04-25 |
| K221772 | NeuroRPM | New Touch Digital, Inc. | 2023-03-17 |
| K220820 | Parky App | H2o Bilisim Yazilim | 2022-11-17 |
| K213519 | Rune Labs Tremor Transducer System | Rune Labs, Inc. | 2022-06-10 |
| K211887 | Personal Kinetigraph (PKG) System Gen 2 Plus | Gkc Manufacturing Pty, Ltd. | 2022-03-11 |
| K140086 | PERSONAL KINETIGRAPH (PKG) SYSTEM | Gkc Manufacturing Pty, Ltd. | 2014-08-22 |
| K063872 | KINESIA | Cleveland Medical Devices, Inc. | 2007-04-06 |
| K010270 | TREMOROMETER | Flexable Systems, Inc. | 2001-07-25 |
| K011429 | MODEL 100 ACTIVITY MONITOR | Telecom Medical, Inc. | 2001-07-13 |
| K971318 | MM-1 MOVEMENT MONITOR | Axon Instruments, Inc. | 1997-07-28 |
| K782036 | TREMOR MONITOR | Columbus Instruments Intl. Corp. | 1979-01-23 |
Legacy Summary#
summary
FDA Review#
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