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FDA 510(k)

MP3U, POWER WHEELCHAIR

K-Number: K011513 · 2001-08-10

ApplicantMerits Health Products., Inc.
Decision Date2001-08-10
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MP3U, POWER WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Merits Health Products., Inc.. It received FDA 510(k) clearance on 2001-08-10 under 510(k) number K011513. 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 MP3U, POWER WHEELCHAIR?

MP3U, POWER WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2001-08-10. The listed applicant is Merits Health Products., Inc.. The 510(k) number is K011513.

When did MP3U, POWER WHEELCHAIR receive FDA 510(k) clearance?

MP3U, POWER WHEELCHAIR received FDA 510(k) clearance on 2001-08-10, under 510(k) number K011513.

Who is the listed applicant for MP3U, POWER WHEELCHAIR?

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

What is the FDA product code for MP3U, POWER WHEELCHAIR?

The FDA product code for MP3U, POWER WHEELCHAIR is ITI.

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Other records listing Merits Health Products., 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.

K012802MP3CF ELECTRIC WHEELCHAIRK011844MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORSK011751TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3K011753TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4K011687MP-3C POWER BASE CHAIR, MODEL MP3CK010380MP3HD BIG BOY, POWER WHEELCHAIR

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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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