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)

Electric Scooter (DDF100)

K-Number: K252275 · 2026-01-29

ApplicantZhejiang Nysin Medical Co., Ltd.
Decision Date2026-01-29
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Electric Scooter (DDF100) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Nysin Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-01-29 under 510(k) number K252275. 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 (DDF100)?

Electric Scooter (DDF100) is a medical device that received FDA 510(k) clearance on 2026-01-29. The listed applicant is Zhejiang Nysin Medical Co., Ltd.. The 510(k) number is K252275.

When did Electric Scooter (DDF100) receive FDA 510(k) clearance?

Electric Scooter (DDF100) received FDA 510(k) clearance on 2026-01-29, under 510(k) number K252275.

Who is the listed applicant for Electric Scooter (DDF100)?

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

What is the FDA product code for Electric Scooter (DDF100)?

The FDA product code for Electric Scooter (DDF100) is INI.

Other records listing Zhejiang Nysin Medical 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.

K241529Powered Wheelchair (NXN20-209)K241603Powered Wheelchair (NXN20-208, NXN20-211)K241379Powered Wheelchair (NXN20-205, NXN20-205M)

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.

↑