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510(k) K840636

CHILDREN'S WHEELCHAIRS by Poirier S.A. — Product Code IQC

K840636 is an FDA 510(k) premarket notification submitted by Poirier S.A. for the device "CHILDREN'S WHEELCHAIRS". The FDA issued a decision of Substantially Equivalent on February 27, 1984. The device falls under product code IQC (Wheelchair, Special Grade), a Class II device regulated under 21 CFR 890.3880. Poirier S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1984
Date Received
January 20, 1984
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 by Poirier S.A.

  • K840638 — PORTABLE TRANSIT CHAIR (March 16, 1984)
  • K840639 — POIRIER COMMODES (March 9, 1984)
  • K840632 — HEMIPLEGIC WHEELCHAIR (February 27, 1984)
  • K840634 — OLYMPIC & BASKET WHEELCHAIRS (February 27, 1984)
  • K840640 — POSITELEC WHEELCHAIR (February 27, 1984)
  • K840630 — POIRIER REGLADE WHEELCHAIR (February 27, 1984)
  • K840633 — AIRPORT WHEELCHAIR (February 27, 1984)
  • K840234 — POIRIER VARIABLE WHEELCHAIR (February 27, 1984)
  • K840627 — AMPUTEE WHEELCHAIR (February 27, 1984)
  • K840631 — ARNAS WHEELCHAIR (February 27, 1984)

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)
  • 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)

FDA data resources