Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Mobility Scooter (W3483, W3483A)

K-Number: K260176 · 2026-08-10

ApplicantZhejiang Innuovo Rehabilitation Devices Co.,Ltd
Decision Date2026-08-10
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Mobility Scooter (W3483, W3483A) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. It received FDA 510(k) clearance on 2026-08-10 under 510(k) number K260176. 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 (W3483, W3483A)?

Mobility Scooter (W3483, W3483A) is a medical device that received FDA 510(k) clearance on 2026-08-10. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. The 510(k) number is K260176.

When did Mobility Scooter (W3483, W3483A) receive FDA 510(k) clearance?

Mobility Scooter (W3483, W3483A) received FDA 510(k) clearance on 2026-08-10, under 510(k) number K260176.

Who is the listed applicant for Mobility Scooter (W3483, W3483A)?

The FDA 510(k) record lists Zhejiang Innuovo Rehabilitation Devices Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mobility Scooter (W3483, W3483A)?

The FDA product code for Mobility Scooter (W3483, W3483A) is INI.

Other records listing Zhejiang Innuovo Rehabilitation Devices 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.

K260094Mobility Scooter (W3465, W3902 (S50 Carbon))K253812Power Wheelchair (W5915B, W5915C, W5915D)K260056Power Wheelchair (N5515A, N5516, N5517A, N5519)K253806Power Wheelchair (N5919 series)K242471Power Wheelchair (W5538)K242387Mobility Scooter (N3473)

View all 20 devices →

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.

K260094Mobility 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.K260717Mobility Scooter (Air Carbon)Suzhou Sweetrich Vehicle Industry Technology 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.

↑