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FDA 510(k)

CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR

K-Number: K080385 · 2008-05-13

ApplicantE1 Ent., Inc.
Decision Date2008-05-13
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is E1 Ent., Inc.. It received FDA 510(k) clearance on 2008-05-13 under 510(k) number K080385. 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 CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR?

CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2008-05-13. The listed applicant is E1 Ent., Inc.. The 510(k) number is K080385.

When did CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR receive FDA 510(k) clearance?

CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR received FDA 510(k) clearance on 2008-05-13, under 510(k) number K080385.

Who is the listed applicant for CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR?

The FDA 510(k) record lists E1 Ent., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR?

The FDA product code for CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR is ITI.

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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

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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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