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FDA 510(k)

AMIGO MODEL 680000 (AMIGO EXCITE F 350)

K-Number: K992619 · 1999-10-25

ApplicantAmigo Mobility Intl., Inc.
Decision Date1999-10-25
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AMIGO MODEL 680000 (AMIGO EXCITE F 350) 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 1999-10-25 under 510(k) number K992619. 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 MODEL 680000 (AMIGO EXCITE F 350)?

AMIGO MODEL 680000 (AMIGO EXCITE F 350) is a medical device that received FDA 510(k) clearance on 1999-10-25. The listed applicant is Amigo Mobility Intl., Inc.. The 510(k) number is K992619.

When did AMIGO MODEL 680000 (AMIGO EXCITE F 350) receive FDA 510(k) clearance?

AMIGO MODEL 680000 (AMIGO EXCITE F 350) received FDA 510(k) clearance on 1999-10-25, under 510(k) number K992619.

Who is the listed applicant for AMIGO MODEL 680000 (AMIGO EXCITE F 350)?

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 MODEL 680000 (AMIGO EXCITE F 350)?

The FDA product code for AMIGO MODEL 680000 (AMIGO EXCITE F 350) 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.

K101507AMIGO CLASSIC FDK092936AMIGO ESCORT 7.5, MODEL 760001 PHSK010503AMIGO WHEELCHAIRK983987AMIGO MODEL 590000K981121AMIGO RTK952112AMIGO GRAND TOUR

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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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