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FDA 510(k)

i3 Foldable Mobility Scooter

K-Number: K191356 · 2022-01-11

ApplicantPuc Perfect Union Co., Ltd.
Decision Date2022-01-11
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

i3 Foldable Mobility Scooter is the device name listed in this FDA 510(k) record. The listed applicant is Puc Perfect Union Co., Ltd.. It received FDA 510(k) clearance on 2022-01-11 under 510(k) number K191356. 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 i3 Foldable Mobility Scooter?

i3 Foldable Mobility Scooter is a medical device that received FDA 510(k) clearance on 2022-01-11. The listed applicant is Puc Perfect Union Co., Ltd.. The 510(k) number is K191356.

When did i3 Foldable Mobility Scooter receive FDA 510(k) clearance?

i3 Foldable Mobility Scooter received FDA 510(k) clearance on 2022-01-11, under 510(k) number K191356.

Who is the listed applicant for i3 Foldable Mobility Scooter?

The FDA 510(k) record lists Puc Perfect Union Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i3 Foldable Mobility Scooter?

The FDA product code for i3 Foldable Mobility Scooter is INI.

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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