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510(k) K842719

STANDARD WHEELCHAIR by Greene International Corp. — Product Code IQC

K842719 is an FDA 510(k) premarket notification submitted by Greene International Corp. for the device "STANDARD WHEELCHAIR". The FDA issued a decision of Substantially Equivalent on July 25, 1984. The device falls under product code IQC (Wheelchair, Special Grade), a Class II device regulated under 21 CFR 890.3880. Greene International Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1984
Date Received
July 13, 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 Greene International Corp.

  • K883827 — MASKS, VARIOUS TYPES OF SURGICAL MASKS (November 17, 1988)
  • K883828 — CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS (October 3, 1988)
  • K880484 — SURGICAL GARMENTS (June 27, 1988)
  • K870617 — VARIOUS TYES OF SURGICAL GARMENTS (March 9, 1987)
  • K843075 — UTILITY SCISSORS DISPOSABLE ITEMS (September 5, 1984)
  • K843073 — FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP (August 24, 1984)
  • K843074 — DISPOS. & SPONGE FORCEPS PEAN ARTERY (August 17, 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)
  • K840634 — OLYMPIC & BASKET WHEELCHAIRS (February 27, 1984)
  • K840632 — HEMIPLEGIC WHEELCHAIR (February 27, 1984)
  • K840630 — POIRIER REGLADE WHEELCHAIR (February 27, 1984)

FDA data resources