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FDA 510(k)

POWERCHAIR

K-Number: K954135 · 1996-04-10

ApplicantWheelcare Scooters, Inc.
Decision Date1996-04-10
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

POWERCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Wheelcare Scooters, Inc.. It received FDA 510(k) clearance on 1996-04-10 under 510(k) number K954135. 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 POWERCHAIR?

POWERCHAIR is a medical device that received FDA 510(k) clearance on 1996-04-10. The listed applicant is Wheelcare Scooters, Inc.. The 510(k) number is K954135.

When did POWERCHAIR receive FDA 510(k) clearance?

POWERCHAIR received FDA 510(k) clearance on 1996-04-10, under 510(k) number K954135.

Who is the listed applicant for POWERCHAIR?

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

What is the FDA product code for POWERCHAIR?

The FDA product code for POWERCHAIR 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 Wheelcare Scooters, Inc. 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.

K964954SUPERLIGHT

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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