RT300 FES cycle ergometer
K-Number: K162470 · 2017-07-11
ApplicantRestorative Therapies, Inc.
Decision Date2017-07-11
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
RT300 FES cycle ergometer is a medical device manufactured by Restorative Therapies, Inc.. It received FDA 510(k) clearance on 2017-07-11 under approval number K162470. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RT300 FES cycle ergometer?
RT300 FES cycle ergometer is a medical device that received FDA 510(k) clearance on 2017-07-11. It is manufactured by Restorative Therapies, Inc.. The 510(k) number is K162470.
When was RT300 FES cycle ergometer approved by the FDA?
RT300 FES cycle ergometer received FDA 510(k) clearance on 2017-07-11, under approval number K162470.
What company makes RT300 FES cycle ergometer?
RT300 FES cycle ergometer is manufactured by Restorative Therapies, Inc..
What is the FDA product code for RT300 FES cycle ergometer?
The FDA product code for RT300 FES cycle ergometer is GZI.
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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.