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FDA 510(k)

RUIKE 3421 POWERED WHEELCHAIR

K-Number: K070501 · 2007-03-22

ApplicantShanghai Ruike Sports Goods Co., Ltd.
Decision Date2007-03-22
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

RUIKE 3421 POWERED WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Ruike Sports Goods Co., Ltd.. It received FDA 510(k) clearance on 2007-03-22 under 510(k) number K070501. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUIKE 3421 POWERED WHEELCHAIR?

RUIKE 3421 POWERED WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2007-03-22. The listed applicant is Shanghai Ruike Sports Goods Co., Ltd.. The 510(k) number is K070501.

When did RUIKE 3421 POWERED WHEELCHAIR receive FDA 510(k) clearance?

RUIKE 3421 POWERED WHEELCHAIR received FDA 510(k) clearance on 2007-03-22, under 510(k) number K070501.

Who is the listed applicant for RUIKE 3421 POWERED WHEELCHAIR?

The FDA 510(k) record lists Shanghai Ruike Sports Goods Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUIKE 3421 POWERED WHEELCHAIR?

The FDA product code for RUIKE 3421 POWERED WHEELCHAIR is ITI.

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 Shanghai Ruike Sports Goods Co., Ltd. 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.

K062646RUIKE, MODEL 3411K062645RUIKE, MODEL 3431K062676RUIKE, MODEL 3331

Related Devices (Code: ITI)

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.

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance 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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