Home / 510(k) Clearances / K251799

510(k) K251799

Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06) by Jiangsu Bangbang Intelligent Technology Co., Ltd. — Product Code INI

K251799 is an FDA 510(k) premarket notification submitted by Jiangsu Bangbang Intelligent Technology Co., Ltd. for the device "Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06)". The FDA issued a decision of Substantially Equivalent on September 30, 2025. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2025
Date Received
June 12, 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 for product code INI

  • K261232 — IERO Mobility Scooter (IERO-01) (July 14, 2026)
  • K261163 — Mobility Scooter (R200) (July 7, 2026)
  • K253257 — Virgo Mobility Scooter (Virgo-D,Virgo-F) (June 8, 2026)
  • K253600 — Scooter (YD-03) (June 3, 2026)
  • K260717 — Mobility Scooter (Air Carbon) (May 20, 2026)
  • K260237 — Mobility Scooter (X-12, X-14, X-17) (April 22, 2026)
  • 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)

FDA data resources