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FDA 510(k)

WORLD CLASS WHEELED CHAIR, MODEL SS

K-Number: K984457 · 1999-01-19

ApplicantSuiter Medical LLC
Decision Date1999-01-19
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

WORLD CLASS WHEELED CHAIR, MODEL SS is the device name listed in this FDA 510(k) record. The listed applicant is Suiter Medical LLC. It received FDA 510(k) clearance on 1999-01-19 under 510(k) number K984457. 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 WORLD CLASS WHEELED CHAIR, MODEL SS?

WORLD CLASS WHEELED CHAIR, MODEL SS is a medical device that received FDA 510(k) clearance on 1999-01-19. The listed applicant is Suiter Medical LLC. The 510(k) number is K984457.

When did WORLD CLASS WHEELED CHAIR, MODEL SS receive FDA 510(k) clearance?

WORLD CLASS WHEELED CHAIR, MODEL SS received FDA 510(k) clearance on 1999-01-19, under 510(k) number K984457.

Who is the listed applicant for WORLD CLASS WHEELED CHAIR, MODEL SS?

The FDA 510(k) record lists Suiter Medical LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WORLD CLASS WHEELED CHAIR, MODEL SS?

The FDA product code for WORLD CLASS WHEELED CHAIR, MODEL SS 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 Suiter Medical LLC 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.

K002876JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM

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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