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FDA 510(k)

DOMINATOR

K-Number: K983681 · 1998-11-27

ApplicantImpact Wheelchair Manufacture, Inc.
Decision Date1998-11-27
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DOMINATOR is the device name listed in this FDA 510(k) record. The listed applicant is Impact Wheelchair Manufacture, Inc.. It received FDA 510(k) clearance on 1998-11-27 under 510(k) number K983681. 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 DOMINATOR?

DOMINATOR is a medical device that received FDA 510(k) clearance on 1998-11-27. The listed applicant is Impact Wheelchair Manufacture, Inc.. The 510(k) number is K983681.

When did DOMINATOR receive FDA 510(k) clearance?

DOMINATOR received FDA 510(k) clearance on 1998-11-27, under 510(k) number K983681.

Who is the listed applicant for DOMINATOR?

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

What is the FDA product code for DOMINATOR?

The FDA product code for DOMINATOR 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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