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FDA 510(k)

SPECTRUM LIBRE WHEELCHAIR

K-Number: K993640 · 1999-11-16

ApplicantFreedom Designs, Inc.
Decision Date1999-11-16
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPECTRUM LIBRE 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 1999-11-16 under 510(k) number K993640. 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 SPECTRUM LIBRE WHEELCHAIR?

SPECTRUM LIBRE WHEELCHAIR is a medical device that received FDA 510(k) clearance on 1999-11-16. The listed applicant is Freedom Designs, Inc.. The 510(k) number is K993640.

When did SPECTRUM LIBRE WHEELCHAIR receive FDA 510(k) clearance?

SPECTRUM LIBRE WHEELCHAIR received FDA 510(k) clearance on 1999-11-16, under 510(k) number K993640.

Who is the listed applicant for SPECTRUM LIBRE 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 SPECTRUM LIBRE WHEELCHAIR?

The FDA product code for SPECTRUM LIBRE 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.

K080270MANUAL RIGID MOBILITY WHEELCHAIRK060926TRIPODK040622FREEDOM HPK023574GIZMOK983859SPECTRUM 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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