Xcite Clinical Station
K-Number: K160614 · 2016-12-16
ApplicantRestorative Therapies, Inc.
Decision Date2016-12-16
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Xcite Clinical Station is a medical device manufactured by Restorative Therapies, Inc.. It received FDA 510(k) clearance on 2016-12-16 under approval number K160614. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Xcite Clinical Station?
Xcite Clinical Station is a medical device that received FDA 510(k) clearance on 2016-12-16. It is manufactured by Restorative Therapies, Inc.. The 510(k) number is K160614.
When was Xcite Clinical Station approved by the FDA?
Xcite Clinical Station received FDA 510(k) clearance on 2016-12-16, under approval number K160614.
What company makes Xcite Clinical Station?
Xcite Clinical Station is manufactured by Restorative Therapies, Inc..
What is the FDA product code for Xcite Clinical Station?
The FDA product code for Xcite Clinical Station is IPF.
Related Clinical Trials
Other Devices by Restorative Therapies, Inc.
Related Devices (Code: IPF)
K163067CyMedica e-vive System; CY-1000Cymedica Orthopedics, Inc.
K160992HPM-6000BTL Industries, Inc.
K151922StimSox(TM) SystemStimmed, LLC
K153696Chattanooga Revolution WirelessDjo, LLC
K160299geko(TM) Plus R-2 Neuromuscular StimulatorFirstkind Limited
K153224VitalStim(R) Plus Electrotherapy SystemDjo, LLC
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.