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510(k) K250027

Powered Mobility Scooter by Intradin (Shanghai) Machinery Co., Ltd. — Product Code INI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2025
Date Received
January 6, 2025
Clearance Type
Special
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 Intradin (Shanghai) Machinery Co., Ltd.

  • K252590 — Powered Mobility Scooter (PMS105, GUT177, GCAT047) (November 21, 2025)
  • K243970 — Portable Wheelchair (March 7, 2025)
  • K232692 — Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) (September 5, 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)
  • K252275 — Electric Scooter (DDF100) (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)