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FDA 510(k)

Scooter (Model: FDB01)

K-Number: K201196 · 2021-06-25

ApplicantNanjing Jin Bai HE Medical Apparatus Co., Ltd.
Decision Date2021-06-25
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Scooter (Model: FDB01) is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Jin Bai HE Medical Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2021-06-25 under 510(k) number K201196. 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 Scooter (Model: FDB01)?

Scooter (Model: FDB01) is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is Nanjing Jin Bai HE Medical Apparatus Co., Ltd.. The 510(k) number is K201196.

When did Scooter (Model: FDB01) receive FDA 510(k) clearance?

Scooter (Model: FDB01) received FDA 510(k) clearance on 2021-06-25, under 510(k) number K201196.

Who is the listed applicant for Scooter (Model: FDB01)?

The FDA 510(k) record lists Nanjing Jin Bai HE Medical Apparatus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Scooter (Model: FDB01)?

The FDA product code for Scooter (Model: FDB01) is INI.

Other records listing Nanjing Jin Bai HE Medical Apparatus 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.

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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.

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

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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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