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FDA 510(k)

SOLUTION

K-Number: K944970 · 1994-12-13

ApplicantFreedom Designs, Inc.
Decision Date1994-12-13
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SOLUTION 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 1994-12-13 under 510(k) number K944970. 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 SOLUTION?

SOLUTION is a medical device that received FDA 510(k) clearance on 1994-12-13. The listed applicant is Freedom Designs, Inc.. The 510(k) number is K944970.

When did SOLUTION receive FDA 510(k) clearance?

SOLUTION received FDA 510(k) clearance on 1994-12-13, under 510(k) number K944970.

Who is the listed applicant for SOLUTION?

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 SOLUTION?

The FDA product code for SOLUTION is IOR.

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Related PubMed Literature

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.

PMID: 30446241A review of international medical device regulations: Contact lenses and lens care solutions.Contact lens & anterior eye : the journal of the British Contact Lens Association ()

Other records listing Freedom Designs, Inc. as applicant

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K080270MANUAL RIGID MOBILITY WHEELCHAIRK060926TRIPODK040622FREEDOM HPK023574GIZMOK993640SPECTRUM LIBRE WHEELCHAIRK983859SPECTRUM SMALL FRY

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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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