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FDA 510(k)

RUIKE, MODEL 3431

K-Number: K062645 · 2006-12-19

ApplicantShanghai Ruike Sports Goods Co., Ltd.
Decision Date2006-12-19
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

RUIKE, MODEL 3431 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 2006-12-19 under 510(k) number K062645. 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 RUIKE, MODEL 3431?

RUIKE, MODEL 3431 is a medical device that received FDA 510(k) clearance on 2006-12-19. The listed applicant is Shanghai Ruike Sports Goods Co., Ltd.. The 510(k) number is K062645.

When did RUIKE, MODEL 3431 receive FDA 510(k) clearance?

RUIKE, MODEL 3431 received FDA 510(k) clearance on 2006-12-19, under 510(k) number K062645.

Who is the listed applicant for RUIKE, MODEL 3431?

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, MODEL 3431?

The FDA product code for RUIKE, MODEL 3431 is INI.

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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.

K070501RUIKE 3421 POWERED WHEELCHAIRK062646RUIKE, MODEL 3411K062676RUIKE, MODEL 3331

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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