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FDA 510(k)

BREEZE C MODEL C (3W), BREEZE C (4W)

K-Number: K102304 · 2011-01-07

ApplicantAfikim Electric Vehicles
Decision Date2011-01-07
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BREEZE C MODEL C (3W), BREEZE C (4W) is the device name listed in this FDA 510(k) record. The listed applicant is Afikim Electric Vehicles. It received FDA 510(k) clearance on 2011-01-07 under 510(k) number K102304. 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 BREEZE C MODEL C (3W), BREEZE C (4W)?

BREEZE C MODEL C (3W), BREEZE C (4W) is a medical device that received FDA 510(k) clearance on 2011-01-07. The listed applicant is Afikim Electric Vehicles. The 510(k) number is K102304.

When did BREEZE C MODEL C (3W), BREEZE C (4W) receive FDA 510(k) clearance?

BREEZE C MODEL C (3W), BREEZE C (4W) received FDA 510(k) clearance on 2011-01-07, under 510(k) number K102304.

Who is the listed applicant for BREEZE C MODEL C (3W), BREEZE C (4W)?

The FDA 510(k) record lists Afikim Electric Vehicles as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BREEZE C MODEL C (3W), BREEZE C (4W)?

The FDA product code for BREEZE C MODEL C (3W), BREEZE C (4W) is INI.

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Other records listing Afikim Electric Vehicles 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.

K051028BREEZEK041186CADDY

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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