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FDA 510(k)

RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053

K-Number: K060032 · 2006-03-10

ApplicantRestorative Therapies, Inc.
Decision Date2006-03-10
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 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 2006-03-10 under 510(k) number K060032. 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-S, MODEL FA100052; RT300-SP, MODEL FA100053?

RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 is a medical device that received FDA 510(k) clearance on 2006-03-10. The listed applicant is Restorative Therapies, Inc.. The 510(k) number is K060032.

When did RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 receive FDA 510(k) clearance?

RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 received FDA 510(k) clearance on 2006-03-10, under 510(k) number K060032.

Who is the listed applicant for RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053?

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-S, MODEL FA100052; RT300-SP, MODEL FA100053?

The FDA product code for RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 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 StationK103370RT200K103366RT600K090750RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581K072398RT300-S AND RT300-SP FES CYCLE ERGOMETER

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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.

K242704Synchrony (20-3000)Synapse Biomedical, Inc.K243828CIONIC NEURAL SLEEVE (NS-200)Cionic, Inc.K240632Neuvotion NeuStim NN-01Neuvotion, Inc.K233006MyndMove, MyndMove 2.0Myndtec, Inc.K230997EvoWalk 1.0 SystemEvolution Devices, Inc.K221823Cionic Neural Sleeve NS-100Cionic

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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