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FDA 510(k)

ZIP'R3/ ZIP'R3 XTRA SCOOTER

K-Number: K102358 · 2010-10-04

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

Device Summary

ZIP'R3/ ZIP'R3 XTRA SCOOTER 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 K102358. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIP'R3/ ZIP'R3 XTRA SCOOTER?

ZIP'R3/ ZIP'R3 XTRA SCOOTER 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 K102358.

When did ZIP'R3/ ZIP'R3 XTRA SCOOTER receive FDA 510(k) clearance?

ZIP'R3/ ZIP'R3 XTRA SCOOTER received FDA 510(k) clearance on 2010-10-04, under 510(k) number K102358.

Who is the listed applicant for ZIP'R3/ ZIP'R3 XTRA SCOOTER?

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'R3/ ZIP'R3 XTRA SCOOTER?

The FDA product code for ZIP'R3/ ZIP'R3 XTRA SCOOTER is INI.

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 SCOOTERK102355ZIP'R MANTIS POWERED WHEELCHAIRK072224ZIP'R PC

Related Devices (Code: INI)

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.

K261078Electric Scooter (FNS01,FNS03)Anhui Jbh Medical Apparatus Co., Ltd.K261859Electric Scooter (FDB08, FDB08A, FDB12)Anhui JBH Medical Apparatus Co., Ltd.K260094Mobility Scooter (W3465, W3902 (S50 Carbon))Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260176Mobility Scooter (W3483, W3483A)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK261232IERO Mobility Scooter (IERO-01)Jochu Technology Co., Ltd.K261163Mobility Scooter (R200)Yongkang Ruihe Metal Product 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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