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FDA 510(k)

Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)

K-Number: K231472 · 2023-07-19

ApplicantSuzhou Sweetrich Vehicle Industry Technology Co., Ltd.
Decision Date2023-07-19
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-07-19 under 510(k) number K231472. 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 Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)?

Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) is a medical device that received FDA 510(k) clearance on 2023-07-19. The listed applicant is Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.. The 510(k) number is K231472.

When did Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) receive FDA 510(k) clearance?

Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) received FDA 510(k) clearance on 2023-07-19, under 510(k) number K231472.

Who is the listed applicant for Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)?

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

What is the FDA product code for Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)?

The FDA product code for Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) is INI.

Other records listing Suzhou Sweetrich Vehicle Industry 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.

K260717Mobility Scooter (Air Carbon)K253075Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)

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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