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FDA 510(k)

LANDLEX MODEL S400X

K-Number: K050793 · 2005-07-07

ApplicantCycling and Health Tech. Industry R&D Center
Decision Date2005-07-07
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LANDLEX MODEL S400X 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 2005-07-07 under 510(k) number K050793. 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 S400X?

LANDLEX MODEL S400X is a medical device that received FDA 510(k) clearance on 2005-07-07. The listed applicant is Cycling and Health Tech. Industry R&D Center. The 510(k) number is K050793.

When did LANDLEX MODEL S400X receive FDA 510(k) clearance?

LANDLEX MODEL S400X received FDA 510(k) clearance on 2005-07-07, under 510(k) number K050793.

Who is the listed applicant for LANDLEX MODEL S400X?

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 S400X?

The FDA product code for LANDLEX MODEL S400X 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 IK050792LANDLEX, MODEL S300XK043326BEWELL, 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.

K261078Electric Scooter (FNS01,FNS03)Anhui Jbh Medical Apparatus Co., Ltd.K261859Electric Scooter (FDB08, FDB08A, FDB12)Anhui JBH Medical Apparatus Co., Ltd.K260094Mobility Scooter (W3465, W3902 (S50 Carbon))Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260176Mobility Scooter (W3483, W3483A)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK261232IERO Mobility Scooter (IERO-01)Jochu Technology Co., Ltd.K261163Mobility Scooter (R200)Yongkang Ruihe Metal Product Co., Ltd.

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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