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FDA 510(k)

MANUAL RIGID MOBILITY WHEELCHAIR

K-Number: K080270 · 2008-04-16

ApplicantFreedom Designs, Inc.
Decision Date2008-04-16
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MANUAL RIGID MOBILITY WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Freedom Designs, Inc.. It received FDA 510(k) clearance on 2008-04-16 under 510(k) number K080270. 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 MANUAL RIGID MOBILITY WHEELCHAIR?

MANUAL RIGID MOBILITY WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2008-04-16. The listed applicant is Freedom Designs, Inc.. The 510(k) number is K080270.

When did MANUAL RIGID MOBILITY WHEELCHAIR receive FDA 510(k) clearance?

MANUAL RIGID MOBILITY WHEELCHAIR received FDA 510(k) clearance on 2008-04-16, under 510(k) number K080270.

Who is the listed applicant for MANUAL RIGID MOBILITY WHEELCHAIR?

The FDA 510(k) record lists Freedom Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANUAL RIGID MOBILITY WHEELCHAIR?

The FDA product code for MANUAL RIGID MOBILITY WHEELCHAIR is IOR.

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Other records listing Freedom Designs, Inc. 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.

K060926TRIPODK040622FREEDOM HPK023574GIZMOK993640SPECTRUM LIBRE WHEELCHAIRK983859SPECTRUM SMALL FRYK983763SPECTRUM SPIRIT

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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

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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