Personal Kinetigraph (PKG) System
K-Number: K161717 · 2016-09-20
ApplicantGkc Manufacturing Pty, Ltd.
Decision Date2016-09-20
Product CodeGYD
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Personal Kinetigraph (PKG) System is a medical device manufactured by Gkc Manufacturing Pty, Ltd.. It received FDA 510(k) clearance on 2016-09-20 under approval number K161717. The device is classified under product code GYD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Personal Kinetigraph (PKG) System?
Personal Kinetigraph (PKG) System is a medical device that received FDA 510(k) clearance on 2016-09-20. It is manufactured by Gkc Manufacturing Pty, Ltd.. The 510(k) number is K161717.
When was Personal Kinetigraph (PKG) System approved by the FDA?
Personal Kinetigraph (PKG) System received FDA 510(k) clearance on 2016-09-20, under approval number K161717.
What company makes Personal Kinetigraph (PKG) System?
Personal Kinetigraph (PKG) System is manufactured by Gkc Manufacturing Pty, Ltd..
What is the FDA product code for Personal Kinetigraph (PKG) System?
The FDA product code for Personal Kinetigraph (PKG) System is GYD.
Related Clinical Trials
NCT07603531
Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema
NOT_YET_RECRUITING
NCT07522944
AI-Guided Relaxation for Hemodialysis Anxiety
RECRUITING
NCT07573098
Digital Tool for Improved Self-management of COPD
RECRUITING
NCT07526818
Comparison of Manual and Mechanical Glide Path Techniques for Measuring Root Canal Length Using Standalone Apex Locator and an Endomotor With built-in Apex Locator.
ACTIVE_NOT_RECRUITING
Other Devices by Gkc Manufacturing Pty, Ltd.
Related Devices (Code: GYD)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.