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510(k) K840638

PORTABLE TRANSIT CHAIR by Poirier S.A. — Product Code INM

K840638 is an FDA 510(k) premarket notification submitted by Poirier S.A. for the device "PORTABLE TRANSIT CHAIR". The FDA issued a decision of Substantially Equivalent on March 16, 1984. The device falls under product code INM (Chair, With Casters), a Class I device regulated under 21 CFR 890.3100. Poirier S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1984
Date Received
January 20, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, With Casters
Device Class
Class I
Regulation Number
890.3100
Review Panel
PM
Submission Type

Other clearances by Poirier S.A.

  • K840639 — POIRIER COMMODES (March 9, 1984)
  • K840626 — VERTICALIBRE WHEELCHAIR (February 27, 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 INM

  • K063521 — NISSIN PEDIATRIC SERIES WHEELCHAIR (February 5, 2007)
  • K941738 — STRYKER 5050 STRECHAIR (May 6, 1994)
  • K941569 — CAREMOR CLINER (April 26, 1994)
  • K933000 — RECLINING GERI CHAIRS W/CASTERS & LAP TRAY (September 30, 1993)
  • K926028 — BENCHES (March 24, 1993)
  • K926053 — ELD-ARONDAK CHAIR (March 22, 1993)
  • K926025 — CHAIRS (March 22, 1993)
  • K926054 — ELD-ARONDAK CHAIR (March 22, 1993)
  • K924848 — KAYE SCOOT-ABOUT, MODEL SB1 (February 12, 1993)
  • K925247 — STONEHEART ROLLER AID (February 12, 1993)

FDA data resources