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510(k) K042612

JAZZY 600 by Pride Mobility Products Corp. — Product Code ITI

K042612 is an FDA 510(k) premarket notification submitted by Pride Mobility Products Corp. for the device "JAZZY 600". The FDA issued a decision of Substantially Equivalent on October 6, 2004. The device falls under product code ITI (Wheelchair, Powered), a Class II device regulated under 21 CFR 890.3860. Pride Mobility Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2004
Date Received
September 24, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Powered
Device Class
Class II
Regulation Number
890.3860
Review Panel
PM
Submission Type

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).

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 ITI

  • K261149 — Electric Wheelchair (DY611A-2, DY612A-1) (July 10, 2026)
  • K261396 — Electric Wheelchair (July 8, 2026)
  • K261164 — Electric wheelchair (XW-LY007 ) (July 7, 2026)
  • K260937 — Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) (June 24, 2026)
  • K253812 — Power Wheelchair (W5915B, W5915C, W5915D) (June 18, 2026)
  • K260335 — Electric Wheelchair (S500-6) (June 15, 2026)
  • K261175 — WHILL (WHILL Model C2) (June 12, 2026)
  • K260056 — Power Wheelchair (N5515A, N5516, N5517A, N5519) (June 5, 2026)
  • K260373 — Electric Wheelchair (DF506) (June 3, 2026)
  • K253241 — Electric Wheelchair (Y207BL) (May 13, 2026)

FDA data resources