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FDA 510(k)

IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7

K-Number: K052008 · 2005-09-16

ApplicantImc-Heart Way LLC
Decision Date2005-09-16
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7 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 2005-09-16 under 510(k) number K052008. 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 - POWER WHEELCHAIR, MODEL HP 7?

IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7 is a medical device that received FDA 510(k) clearance on 2005-09-16. The listed applicant is Imc-Heart Way LLC. The 510(k) number is K052008.

When did IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7 receive FDA 510(k) clearance?

IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7 received FDA 510(k) clearance on 2005-09-16, under 510(k) number K052008.

Who is the listed applicant for IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7?

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 - POWER WHEELCHAIR, MODEL HP 7?

The FDA product code for IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7 is ITI.

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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.

K063328IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6)K063320ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)K063307ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R)K063203ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)K063475IMC-HEARTWAY, LLC ELECTRIC WHEELCHAIR, MODEL TIARA (P4AS)K063474ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)

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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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