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)

ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)

K-Number: K063203 · 2007-02-13

ApplicantImc-Heart Way LLC
Decision Date2007-02-13
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4) is the device name listed in this FDA 510(k) record. The listed applicant is Imc-Heart Way LLC. It received FDA 510(k) clearance on 2007-02-13 under 510(k) number K063203. 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 ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)?

ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4) is a medical device that received FDA 510(k) clearance on 2007-02-13. The listed applicant is Imc-Heart Way LLC. The 510(k) number is K063203.

When did ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4) receive FDA 510(k) clearance?

ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4) received FDA 510(k) clearance on 2007-02-13, under 510(k) number K063203.

Who is the listed applicant for ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)?

The FDA 510(k) record lists Imc-Heart Way LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)?

The FDA product code for ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4) 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

Other records listing Imc-Heart Way 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.

K063328IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)K063320ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)K063307ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R)K063475IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)K063474ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)K052008IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7

View all 10 devices →

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.

↑