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FDA 510(k)

ROUGHRIDER

K-Number: K103212 · 2011-01-03

ApplicantWhirlwind Wheelchair International
Decision Date2011-01-03
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ROUGHRIDER is the device name listed in this FDA 510(k) record. The listed applicant is Whirlwind Wheelchair International. It received FDA 510(k) clearance on 2011-01-03 under 510(k) number K103212. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROUGHRIDER?

ROUGHRIDER is a medical device that received FDA 510(k) clearance on 2011-01-03. The listed applicant is Whirlwind Wheelchair International. The 510(k) number is K103212.

When did ROUGHRIDER receive FDA 510(k) clearance?

ROUGHRIDER received FDA 510(k) clearance on 2011-01-03, under 510(k) number K103212.

Who is the listed applicant for ROUGHRIDER?

The FDA 510(k) record lists Whirlwind Wheelchair International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROUGHRIDER?

The FDA product code for ROUGHRIDER is IOR.

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Related Devices (Code: IOR)

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.

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbHK261919Multifunctional wheelchair (YJ-059)Zhenjiang Assure Medical Equipment Co., Ltd.K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 Wheelchair (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.K260144Reclining wheelchair (YJ-013L)Zhenjiang Assure Medical Equipment Co., Ltd.K261571Manual Wheelchair (H008, PCK7)Jiangsu Yuyue Medical Equipment & Supply 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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