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FDA 510(k)

RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581

K-Number: K090750 · 2009-08-05

ApplicantRestorative Therapies, Inc.
Decision Date2009-08-05
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 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 2009-08-05 under 510(k) number K090750. 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-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581?

RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 is a medical device that received FDA 510(k) clearance on 2009-08-05. The listed applicant is Restorative Therapies, Inc.. The 510(k) number is K090750.

When did RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 receive FDA 510(k) clearance?

RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 received FDA 510(k) clearance on 2009-08-05, under 510(k) number K090750.

Who is the listed applicant for RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581?

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-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581?

The FDA product code for RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 is GZI.

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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 ergometerK160614Xcite Clinical StationK103370RT200K103366RT600K072398RT300-S AND RT300-SP FES CYCLE ERGOMETERK071486RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053

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Related Devices (Code: GZI)

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

View on FDA Database →

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

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