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FDA 510(k)

FES CYCLE ERGOMETER, MODEL RT300-S

K-Number: K050036 · 2005-06-27

ApplicantRestorative Therapies, Inc.
Decision Date2005-06-27
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FES CYCLE ERGOMETER, MODEL RT300-S 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 2005-06-27 under 510(k) number K050036. 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 FES CYCLE ERGOMETER, MODEL RT300-S?

FES CYCLE ERGOMETER, MODEL RT300-S is a medical device that received FDA 510(k) clearance on 2005-06-27. The listed applicant is Restorative Therapies, Inc.. The 510(k) number is K050036.

When did FES CYCLE ERGOMETER, MODEL RT300-S receive FDA 510(k) clearance?

FES CYCLE ERGOMETER, MODEL RT300-S received FDA 510(k) clearance on 2005-06-27, under 510(k) number K050036.

Who is the listed applicant for FES CYCLE ERGOMETER, MODEL RT300-S?

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 FES CYCLE ERGOMETER, MODEL RT300-S?

The FDA product code for FES CYCLE ERGOMETER, MODEL RT300-S 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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