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510(k) K120302

MECHANICAL WHEELCHAIR by Novaf Andalucia 2007, SL — Product Code IQC

K120302 is an FDA 510(k) premarket notification submitted by Novaf Andalucia 2007, SL for the device "MECHANICAL WHEELCHAIR". The FDA issued a decision of Substantially Equivalent on July 6, 2012. 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
July 6, 2012
Date Received
February 1, 2012
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)
  • K082857 — RENEGADE WHEELCHAIR (January 6, 2009)
  • K051709 — HIPPOCAMPE WHEELCHAIR (August 15, 2005)
  • K895384 — CALIFORNIA COMFORT FOUR WHEEL (September 18, 1989)
  • 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