FDA 510(k)

RT300 FES 循环功率自行车

K号: K162470 · 2017-07-11

决定日期2017-07-11

产品代码GZI

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决定实质等同

器械摘要

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.

常见问题

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.

列明Restorative Therapies, Inc.为申报人的其他记录

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