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FDA 510(k)

LANDLEX, MODEL S300X

K-Number: K050792 · 2005-04-21

ApplicantCycling and Health Tech. Industry R&D Center
Decision Date2005-04-21
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LANDLEX, MODEL S300X is the device name listed in this FDA 510(k) record. The listed applicant is Cycling and Health Tech. Industry R&D Center. It received FDA 510(k) clearance on 2005-04-21 under 510(k) number K050792. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LANDLEX, MODEL S300X?

LANDLEX, MODEL S300X is a medical device that received FDA 510(k) clearance on 2005-04-21. The listed applicant is Cycling and Health Tech. Industry R&D Center. The 510(k) number is K050792.

When did LANDLEX, MODEL S300X receive FDA 510(k) clearance?

LANDLEX, MODEL S300X received FDA 510(k) clearance on 2005-04-21, under 510(k) number K050792.

Who is the listed applicant for LANDLEX, MODEL S300X?

The FDA 510(k) record lists Cycling and Health Tech. Industry R&D Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LANDLEX, MODEL S300X?

The FDA product code for LANDLEX, MODEL S300X is INI.

Related Clinical Trials

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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Other records listing Cycling and Health Tech. Industry R&D Center 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.

K050507SMARTECH, MODEL HOLI IK050793LANDLEX MODEL S400XK043326BEWELL, MODEL SC 20K043332WHEELCHAIR, MODEL 8500-II

Related Devices (Code: INI)

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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