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510(k) K003058

LASER 3 SPSC300 by Pride Mobility Products Corp. — Product Code INI

K003058 is an FDA 510(k) premarket notification submitted by Pride Mobility Products Corp. for the device "LASER 3 SPSC300". The FDA issued a decision of Substantially Equivalent on March 8, 2001. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Pride Mobility Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2001
Date Received
October 2, 2000
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 Pride Mobility Products Corp.

  • K111739 — KIDS ROCK 3 CHAIR (August 12, 2011)
  • K091578 — LIFT CHAIR, MODEL T3 (December 2, 2009)
  • K092961 — JAZZY FRONTIE (October 23, 2009)
  • K092088 — VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713 (July 16, 2009)
  • K091113 — MAXIMA V, THREE WHEEL SCOOTER, MODEL SC900V MAXIMA V, FOUR WHEEL SCOOTER, MODEL (May 11, 2009)
  • K090805 — V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS (April 3, 2009)
  • K090524 — GO GO ELITE TRAVELER V THREE WHEEL SCOOTER, MODEL SC40EV (March 19, 2009)
  • K072165 — VICTORY THREE WHEEL SCOOTER, MODEL: SC610 (August 17, 2007)
  • K071949 — VICTORY, 4 WHEEL SCOOTER / MODEL, # SC1740 (August 1, 2007)
  • K070950 — LIFT CHAIR, MODEL C5 (April 16, 2007)

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