Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CHAMPION, 3000

K-Number: K953428 · 1995-07-31

ApplicantKuschall of America
Decision Date1995-07-31
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CHAMPION, 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Kuschall of America. It received FDA 510(k) clearance on 1995-07-31 under 510(k) number K953428. 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 CHAMPION, 3000?

CHAMPION, 3000 is a medical device that received FDA 510(k) clearance on 1995-07-31. The listed applicant is Kuschall of America. The 510(k) number is K953428.

When did CHAMPION, 3000 receive FDA 510(k) clearance?

CHAMPION, 3000 received FDA 510(k) clearance on 1995-07-31, under 510(k) number K953428.

Who is the listed applicant for CHAMPION, 3000?

The FDA 510(k) record lists Kuschall of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHAMPION, 3000?

The FDA product code for CHAMPION, 3000 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Kuschall of America 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.

K953429CHAMPION, 1000K953426COMPETITORK953427CHAMPION, 3000 REBEL

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.

↑