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510(k) K231428

Mobility Scooter (Models: W3431D) by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd — Product Code INI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2023
Date Received
May 17, 2023
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 Innuovo Rehabilitation Devices Co.,Ltd

  • K242471 — Power Wheelchair (W5538) (November 18, 2024)
  • K242387 — Mobility Scooter (N3473) (October 11, 2024)
  • K240990 — Mobility Scooter (September 10, 2024)
  • K240008 — Mobility Scooter (W3331) (June 5, 2024)
  • K240012 — Mobility Scooter (W3431) (May 2, 2024)
  • K230964 — Power Wheelchair (N5909) (December 13, 2023)
  • K231508 — Power Wheelchair, W5521 (November 9, 2023)
  • K222507 — Mobility Scooter (Models: W3431Q, W3431R) (February 28, 2023)
  • K222495 — Mobility Scooter, Model: W3331F (October 17, 2022)
  • K221026 — Power Wheelchair (July 1, 2022)

Other clearances for product code INI

  • K252813 — Electrical Scooter (SM4226) (March 17, 2026)
  • 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)
  • K252349 — Electric Scooter (Mojo-T330) (January 29, 2026)
  • K252347 — Electric Scooter (Mojo-T580) (January 29, 2026)
  • K252275 — Electric Scooter (DDF100) (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)