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)

SOLEUS POWERED WHEELCHAIR, MODEL FAD-2

K-Number: K043511 · 2005-03-14

ApplicantSoleus Champ International Co., Ltd.
Decision Date2005-03-14
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SOLEUS POWERED WHEELCHAIR, MODEL FAD-2 is the device name listed in this FDA 510(k) record. The listed applicant is Soleus Champ International Co., Ltd.. It received FDA 510(k) clearance on 2005-03-14 under 510(k) number K043511. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLEUS POWERED WHEELCHAIR, MODEL FAD-2?

SOLEUS POWERED WHEELCHAIR, MODEL FAD-2 is a medical device that received FDA 510(k) clearance on 2005-03-14. The listed applicant is Soleus Champ International Co., Ltd.. The 510(k) number is K043511.

When did SOLEUS POWERED WHEELCHAIR, MODEL FAD-2 receive FDA 510(k) clearance?

SOLEUS POWERED WHEELCHAIR, MODEL FAD-2 received FDA 510(k) clearance on 2005-03-14, under 510(k) number K043511.

Who is the listed applicant for SOLEUS POWERED WHEELCHAIR, MODEL FAD-2?

The FDA 510(k) record lists Soleus Champ International Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLEUS POWERED WHEELCHAIR, MODEL FAD-2?

The FDA product code for SOLEUS POWERED WHEELCHAIR, MODEL FAD-2 is ITI.

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

Related Devices (Code: ITI)

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.

K262582Electric wheelchair (GP100)Suzhou Green Pine Medical Co., Ltd.K262054Electric WheelchairYongkang Joymax Medical Technology Co., Ltd.K260053Power Wheelchair (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229Electric wheelchair (HC819N, HC830N, HC831N)Yongkang Hengyi Vehicle Co., Ltd.K261354Electric wheelchair (D03)Foshan Sowell Medical Technology Co., Ltd.K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance 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.

↑