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FDA 510(k)

HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR

K-Number: K011744 · 2001-08-24

ApplicantTransworld Mobility Distribution, LLC
Decision Date2001-08-24
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Transworld Mobility Distribution, LLC. It received FDA 510(k) clearance on 2001-08-24 under 510(k) number K011744. 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 HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR?

HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2001-08-24. The listed applicant is Transworld Mobility Distribution, LLC. The 510(k) number is K011744.

When did HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR receive FDA 510(k) clearance?

HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR received FDA 510(k) clearance on 2001-08-24, under 510(k) number K011744.

Who is the listed applicant for HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR?

The FDA 510(k) record lists Transworld Mobility Distribution, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR?

The FDA product code for HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR is ITI.

Related Clinical Trials

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Other records listing Transworld Mobility Distribution, 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.

K020001PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3K020002MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33K011745HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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