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510(k) K251638

Mobility Scooter (MS160C) by Suzhou Master Machinery Manufacturing Co.,Ltd — Product Code INI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2025
Date Received
May 29, 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 Suzhou Master Machinery Manufacturing Co.,Ltd

  • K253870 — Electric Wheelchair (MP148) (March 4, 2026)
  • K252687 — Manual Wheelchair (HM305-Air1, HM305-Air2) (November 21, 2025)
  • K242982 — Mobility Scooter (MS160A) (January 31, 2025)
  • K241463 — Electric Wheelchair (MP201C); Electric Wheelchair (MP201L) (July 18, 2024)
  • K222711 — HS186B Scooter (January 9, 2023)

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)
  • K252275 — Electric Scooter (DDF100) (January 29, 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)