Home / 510(k) Clearances / K895384

510(k) K895384

CALIFORNIA COMFORT FOUR WHEEL by Jubilee Scooters, Inc. — Product Code IQC

K895384 is an FDA 510(k) premarket notification submitted by Jubilee Scooters, Inc. for the device "CALIFORNIA COMFORT FOUR WHEEL". The FDA issued a decision of Substantially Equivalent on September 18, 1989. The device falls under product code IQC (Wheelchair, Special Grade), a Class II device regulated under 21 CFR 890.3880.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1989
Date Received
August 30, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wheelchair, Special Grade
Device Class
Class II
Regulation Number
890.3880
Review Panel
PM
Submission Type

Other clearances for product code IQC

  • K251570 — Hippocampe Marathon and Trail (June 23, 2025)
  • K120302 — MECHANICAL WHEELCHAIR (July 6, 2012)
  • K082857 — RENEGADE WHEELCHAIR (January 6, 2009)
  • K051709 — HIPPOCAMPE WHEELCHAIR (August 15, 2005)
  • K861943 — PCI CUSTOM DESIGN SERIES (May 30, 1986)
  • K843213 — QUALINE WHEELCHAIR PRODUCTS (August 24, 1984)
  • K842719 — STANDARD WHEELCHAIR (July 25, 1984)
  • K840634 — OLYMPIC & BASKET WHEELCHAIRS (February 27, 1984)
  • K840632 — HEMIPLEGIC WHEELCHAIR (February 27, 1984)
  • K840630 — POIRIER REGLADE WHEELCHAIR (February 27, 1984)

FDA data resources