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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Restorative Therapies, Inc.. It received FDA 510(k) clearance on 2016-12-16 under 510(k) 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. The listed applicant is Restorative Therapies, Inc.. The 510(k) number is K160614.

When did Xcite Clinical Station receive FDA 510(k) clearance?

Xcite Clinical Station received FDA 510(k) clearance on 2016-12-16, under 510(k) number K160614.

Who is the listed applicant for Xcite Clinical Station?

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 Xcite Clinical Station?

The FDA product code for Xcite Clinical Station is IPF.

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.

K162470RT300 FES cycle ergometer

Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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.

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