FDA 510(k)

RT300 FES cycle ergometer

K-Number: K162470 · 2017-07-11

Decision Date2017-07-11

Product CodeGZI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

RT300 FES cycle ergometer is the device name listed in this FDA 510(k) record. The listed applicant is Restorative Therapies, Inc.. It received FDA 510(k) clearance on 2017-07-11 under 510(k) 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. The listed applicant is Restorative Therapies, Inc.. The 510(k) number is K162470.

When did RT300 FES cycle ergometer receive FDA 510(k) clearance?

RT300 FES cycle ergometer received FDA 510(k) clearance on 2017-07-11, under 510(k) number K162470.

Who is the listed applicant for RT300 FES cycle ergometer?

The FDA 510(k) record lists Restorative Therapies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RT300 FES cycle ergometer?

The FDA product code for RT300 FES cycle ergometer is GZI.

Other records listing Restorative Therapies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.