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FDA 510(k)

RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053

K-Number: K071486 · 2007-09-10

ApplicantRestorative Therapies, Inc.
Decision Date2007-09-10
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, 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 2007-09-10 under 510(k) number K071486. 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, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053?

RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 is a medical device that received FDA 510(k) clearance on 2007-09-10. The listed applicant is Restorative Therapies, Inc.. The 510(k) number is K071486.

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

RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 received FDA 510(k) clearance on 2007-09-10, under 510(k) number K071486.

Who is the listed applicant for RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, 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, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053?

The FDA product code for RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 is GZI.

Related Clinical Trials

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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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