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FDA 510(k)

REGAL MOTORIZIED 3 WHEELED VEHICLE

K-Number: K921647 · 1992-05-04

ApplicantBruno Independent Living Aids, Inc.
Decision Date1992-05-04
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

REGAL MOTORIZIED 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 1992-05-04 under 510(k) number K921647. 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 REGAL MOTORIZIED 3 WHEELED VEHICLE?

REGAL MOTORIZIED 3 WHEELED VEHICLE is a medical device that received FDA 510(k) clearance on 1992-05-04. The listed applicant is Bruno Independent Living Aids, Inc.. The 510(k) number is K921647.

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

REGAL MOTORIZIED 3 WHEELED VEHICLE received FDA 510(k) clearance on 1992-05-04, under 510(k) number K921647.

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

The FDA product code for REGAL MOTORIZIED 3 WHEELED VEHICLE is INI.

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

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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

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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