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)

SWEDE CHAMP (WHEELCHAIR)

K-Number: K875034 · 1988-01-12

ApplicantEtac Us, Inc.
Decision Date1988-01-12
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SWEDE CHAMP (WHEELCHAIR) is the device name listed in this FDA 510(k) record. The listed applicant is Etac Us, Inc.. It received FDA 510(k) clearance on 1988-01-12 under 510(k) number K875034. 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 SWEDE CHAMP (WHEELCHAIR)?

SWEDE CHAMP (WHEELCHAIR) is a medical device that received FDA 510(k) clearance on 1988-01-12. The listed applicant is Etac Us, Inc.. The 510(k) number is K875034.

When did SWEDE CHAMP (WHEELCHAIR) receive FDA 510(k) clearance?

SWEDE CHAMP (WHEELCHAIR) received FDA 510(k) clearance on 1988-01-12, under 510(k) number K875034.

Who is the listed applicant for SWEDE CHAMP (WHEELCHAIR)?

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

What is the FDA product code for SWEDE CHAMP (WHEELCHAIR)?

The FDA product code for SWEDE CHAMP (WHEELCHAIR) 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 Etac Us, Inc. 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.

K923428PANDAK914610SWEDE CROSS MANUAL WHEELCHAIRK883275SWEDE ELITE, MECHANICAL WHEELCHAIRK875035SWEDE PETITE (WHEELCHAIR)

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.

↑