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FDA 510(k)

ZIP'R MANTIS POWERED WHEELCHAIR

K-Number: K102355 · 2010-10-04

ApplicantGlobal Fabtech Wheelchair (Shanghai) Co., Ltd.
Decision Date2010-10-04
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ZIP'R MANTIS POWERED WHEELCHAIR is the device name listed in this FDA 510(k) record. The listed applicant is Global Fabtech Wheelchair (Shanghai) Co., Ltd.. It received FDA 510(k) clearance on 2010-10-04 under 510(k) number K102355. 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 ZIP'R MANTIS POWERED WHEELCHAIR?

ZIP'R MANTIS POWERED WHEELCHAIR is a medical device that received FDA 510(k) clearance on 2010-10-04. The listed applicant is Global Fabtech Wheelchair (Shanghai) Co., Ltd.. The 510(k) number is K102355.

When did ZIP'R MANTIS POWERED WHEELCHAIR receive FDA 510(k) clearance?

ZIP'R MANTIS POWERED WHEELCHAIR received FDA 510(k) clearance on 2010-10-04, under 510(k) number K102355.

Who is the listed applicant for ZIP'R MANTIS POWERED WHEELCHAIR?

The FDA 510(k) record lists Global Fabtech Wheelchair (Shanghai) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZIP'R MANTIS POWERED WHEELCHAIR?

The FDA product code for ZIP'R MANTIS POWERED WHEELCHAIR 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 Global Fabtech Wheelchair (Shanghai) Co., Ltd. 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.

K102361ZIP'R4/ ZIP'R4 XTRA SCOOTERK102358ZIP'R3/ ZIP'R3 XTRA SCOOTERK072224ZIP'R PC

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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