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FDA 510(k)

MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR

K-Number: K113577 · 2012-05-08

ApplicantMerits Health Products Co., Ltd.
Decision Date2012-05-08
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Merits Health Products Co., Ltd.. It received FDA 510(k) clearance on 2012-05-08 under 510(k) number K113577. 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 MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR?

MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2012-05-08. The listed applicant is Merits Health Products Co., Ltd.. The 510(k) number is K113577.

When did MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR receive FDA 510(k) clearance?

MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR received FDA 510(k) clearance on 2012-05-08, under 510(k) number K113577.

Who is the listed applicant for MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR?

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

What is the FDA product code for MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR?

The FDA product code for MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR is ITI.

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Other records listing Merits Health Products Co., Ltd. as applicant

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K220529Merits P335 Powered WheelchairK122357MERITS MODEL P322FWD POWERED WHEELCHAIRK092859MERITS MODEL N SERIES NEBULIZER COMPRESSORSK091716MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORYK073110MERITS E600 SERIES STAIR LIFTK073513MERITS E700 PORCE LIFT

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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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