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FDA 510(k)

AMIGO ESCORT 7.5, MODEL 760001 PHS

K-Number: K092936 · 2009-12-04

ApplicantAmigo Mobility Intl., Inc.
Decision Date2009-12-04
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AMIGO ESCORT 7.5, MODEL 760001 PHS is the device name listed in this FDA 510(k) record. The listed applicant is Amigo Mobility Intl., Inc.. It received FDA 510(k) clearance on 2009-12-04 under 510(k) number K092936. 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 AMIGO ESCORT 7.5, MODEL 760001 PHS?

AMIGO ESCORT 7.5, MODEL 760001 PHS is a medical device that received FDA 510(k) clearance on 2009-12-04. The listed applicant is Amigo Mobility Intl., Inc.. The 510(k) number is K092936.

When did AMIGO ESCORT 7.5, MODEL 760001 PHS receive FDA 510(k) clearance?

AMIGO ESCORT 7.5, MODEL 760001 PHS received FDA 510(k) clearance on 2009-12-04, under 510(k) number K092936.

Who is the listed applicant for AMIGO ESCORT 7.5, MODEL 760001 PHS?

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

What is the FDA product code for AMIGO ESCORT 7.5, MODEL 760001 PHS?

The FDA product code for AMIGO ESCORT 7.5, MODEL 760001 PHS is ITI.

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Other records listing Amigo Mobility Intl., 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.

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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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