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510(k) K252275

Electric Scooter (DDF100) by Zhejiang Nysin Medical Co., Ltd. — Product Code INI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2026
Date Received
July 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vehicle, Motorized 3-Wheeled
Device Class
Class II
Regulation Number
890.3800
Review Panel
PM
Submission Type

Other clearances by Zhejiang Nysin Medical Co., Ltd.

  • K241529 — Powered Wheelchair (NXN20-209) (November 22, 2024)
  • K241603 — Powered Wheelchair (NXN20-208, NXN20-211) (November 20, 2024)
  • K241379 — Powered Wheelchair (NXN20-205, NXN20-205M) (September 16, 2024)

Other clearances for product code INI

  • K253936 — Power Mobility Scooter (MJMA01, MJMA02) (March 12, 2026)
  • K253631 — Mobility Scooter (CL-Q3, CL-Q4) (February 23, 2026)
  • K253643 — Mobility Scooter (S3) (February 18, 2026)
  • K252347 — Electric Scooter (Mojo-T580) (January 29, 2026)
  • K252349 — Electric Scooter (Mojo-T330) (January 29, 2026)
  • K253075 — Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scoot (January 9, 2026)
  • K252817 — Mobility Scooter (BC-MS310) (January 2, 2026)
  • K252835 — Electric Scooter (S202572J, S2060, M2089, S2050) (December 23, 2025)
  • K252588 — Mobility Scooter (T5) (December 4, 2025)
  • K252590 — Powered Mobility Scooter (PMS105, GUT177, GCAT047) (November 21, 2025)