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FDA 510(k)

GEN_2 MECHANICAL WHEELCHAIR

K-Number: K113713 · 2012-05-07

ApplicantFree Wheelchair Mission
Decision Date2012-05-07
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GEN_2 MECHANICAL WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Free Wheelchair Mission. It received FDA 510(k) clearance on 2012-05-07 under 510(k) number K113713. 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 GEN_2 MECHANICAL WHEELCHAIR?

GEN_2 MECHANICAL WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2012-05-07. The listed applicant is Free Wheelchair Mission. The 510(k) number is K113713.

When did GEN_2 MECHANICAL WHEELCHAIR receive FDA 510(k) clearance?

GEN_2 MECHANICAL WHEELCHAIR received FDA 510(k) clearance on 2012-05-07, under 510(k) number K113713.

Who is the listed applicant for GEN_2 MECHANICAL WHEELCHAIR?

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

What is the FDA product code for GEN_2 MECHANICAL WHEELCHAIR?

The FDA product code for GEN_2 MECHANICAL WHEELCHAIR is IOR.

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 Free Wheelchair Mission 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.

K252370GEN 4 JOY WheelchairK170701GEN_2 and GEN_3 Mechanical Wheelchairs

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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