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FDA 510(k)

REGAL MOTOTRIZED 3 WHEELED VEHICLE

K-Number: K011227 · 2001-05-11

ApplicantBruno Independent Living Aids, Inc.
Decision Date2001-05-11
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REGAL MOTOTRIZED 3 WHEELED VEHICLE is the device name listed in this FDA 510(k) record. The listed applicant is Bruno Independent Living Aids, Inc.. It received FDA 510(k) clearance on 2001-05-11 under 510(k) number K011227. 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 REGAL MOTOTRIZED 3 WHEELED VEHICLE?

REGAL MOTOTRIZED 3 WHEELED VEHICLE is a medical device that received FDA 510(k) clearance on 2001-05-11. The listed applicant is Bruno Independent Living Aids, Inc.. The 510(k) number is K011227.

When did REGAL MOTOTRIZED 3 WHEELED VEHICLE receive FDA 510(k) clearance?

REGAL MOTOTRIZED 3 WHEELED VEHICLE received FDA 510(k) clearance on 2001-05-11, under 510(k) number K011227.

Who is the listed applicant for REGAL MOTOTRIZED 3 WHEELED VEHICLE?

The FDA 510(k) record lists Bruno Independent Living Aids, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REGAL MOTOTRIZED 3 WHEELED VEHICLE?

The FDA product code for REGAL MOTOTRIZED 3 WHEELED VEHICLE is ITI.

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Other records listing Bruno Independent Living Aids, Inc. as applicant

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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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