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FDA 510(k)

Electric Scooter (Model: S3312)

K-Number: K230615 · 2023-05-05

ApplicantGuangdong Prestige Technology Co., Ltd.
Decision Date2023-05-05
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Electric Scooter (Model: S3312) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Prestige Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-05 under 510(k) number K230615. 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 Electric Scooter (Model: S3312)?

Electric Scooter (Model: S3312) is a medical device that received FDA 510(k) clearance on 2023-05-05. The listed applicant is Guangdong Prestige Technology Co., Ltd.. The 510(k) number is K230615.

When did Electric Scooter (Model: S3312) receive FDA 510(k) clearance?

Electric Scooter (Model: S3312) received FDA 510(k) clearance on 2023-05-05, under 510(k) number K230615.

Who is the listed applicant for Electric Scooter (Model: S3312)?

The FDA 510(k) record lists Guangdong Prestige Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electric Scooter (Model: S3312)?

The FDA product code for Electric Scooter (Model: S3312) is INI.

Other records listing Guangdong Prestige Technology Co., Ltd. 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.

K252835Electric Scooter (S202572J, S2060, M2089, S2050)K240270Electric wheelchair (S7018)K240272Electric Scooter (M2085, S2091)K230001Electric Scooter (Model: M2020)

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.

K260176Mobility Scooter (W3483, W3483A)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260094Mobility Scooter (W3465, W3902 (S50 Carbon))Zhejiang Innuovo Rehabilitation Devices Co.,LtdK261232IERO Mobility Scooter (IERO-01)Jochu Technology Co., Ltd.K261163Mobility Scooter (R200)Yongkang Ruihe Metal Product Co., Ltd.K253257Virgo Mobility Scooter (Virgo-D,Virgo-F)Jiangsu Intco Medical Products Co., Ltd.K253600Scooter (YD-03)Yurob Rehabilitation Medical 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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