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FDA 510(k)

IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)

K-Number: K063328 · 2007-04-27

ApplicantImc-Heart Way LLC
Decision Date2007-04-27
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6) 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 2007-04-27 under 510(k) number K063328. 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 IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)?

IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6) is a medical device that received FDA 510(k) clearance on 2007-04-27. The listed applicant is Imc-Heart Way LLC. The 510(k) number is K063328.

When did IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6) receive FDA 510(k) clearance?

IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6) received FDA 510(k) clearance on 2007-04-27, under 510(k) number K063328.

Who is the listed applicant for IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)?

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 IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)?

The FDA product code for IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6) 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.

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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.

K063307ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R)K063320ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)K063203ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)K063475IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)K063474ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)K052008IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7

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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.

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