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510(k) K941738

STRYKER 5050 STRECHAIR by Stryker Medical — Product Code INM

K941738 is an FDA 510(k) premarket notification submitted by Stryker Medical for the device "STRYKER 5050 STRECHAIR". The FDA issued a decision of Substantially Equivalent on May 6, 1994. The device falls under product code INM (Chair, With Casters), a Class I device regulated under 21 CFR 890.3100. Stryker Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1994
Date Received
April 7, 1994
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 Stryker Medical

  • K222818 — Xpedition ™ Powered Stair Chair (625700000000) (January 24, 2023)
  • K180834 — Altrix Precision Temperature Management System (August 10, 2018)
  • K171149 — Altrix Temperature Management Wraps (July 18, 2017)
  • K152266 — Altrix Precision Temperature Management System (December 2, 2016)
  • K113598 — POWER-LOAD COT FASTENER SYSTEM (December 20, 2011)
  • K946149 — STRYKER AGILITY INTENSIVE CARE BED (March 14, 1995)
  • K943864 — STRYKER 8000 SURGERY STRETCHER (August 25, 1994)
  • K935949 — STRYKER 5000 (June 17, 1994)
  • K940068 — STRYKER OPERATING ROOM TABLE (May 5, 1994)
  • K935297 — STRYKER AMBULANCE COT MODEL 6060 (February 18, 1994)

Other clearances for product code INM

  • K063521 — NISSIN PEDIATRIC SERIES WHEELCHAIR (February 5, 2007)
  • 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)
  • K926054 — ELD-ARONDAK CHAIR (March 22, 1993)
  • K926025 — CHAIRS (March 22, 1993)
  • K924848 — KAYE SCOOT-ABOUT, MODEL SB1 (February 12, 1993)
  • K925247 — STONEHEART ROLLER AID (February 12, 1993)
  • K921917 — DOLOMITE ROLLATOR (May 26, 1992)

FDA data resources