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510(k) K022407

MULTI FUCTIONAL REHABILITATION CHAIR by Raye'S, Inc. — Product Code INO

K022407 is an FDA 510(k) premarket notification submitted by Raye'S, Inc. for the device "MULTI FUCTIONAL REHABILITATION CHAIR". The FDA issued a decision of Substantially Equivalent on August 16, 2002. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110. Raye'S, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2002
Date Received
July 24, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Positioning, Electric
Device Class
Class II
Regulation Number
890.3110
Review Panel
PM
Submission Type

Other clearances by Raye'S, Inc.

  • K002580 — PRAIRIE CRUISER (July 3, 2001)
  • K983497 — OVERLANDER PEV 2000 (June 27, 1999)

Other clearances for product code INO

  • K131909 — DALTON LIFT CHAIR (February 24, 2014)
  • K123834 — EASYSTAND BANTAM MEDIUM (August 13, 2013)
  • K112944 — FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES (December 30, 2011)
  • K101723 — COMPACT WHEELCHAIR PLATFORM (December 23, 2010)
  • K091578 — LIFT CHAIR, MODEL T3 (December 2, 2009)
  • K091727 — MEDICAL TREATMENT CHAIR, T400, T500,T600 (July 6, 2009)
  • K091242 — BANTAM (July 6, 2009)
  • K073565 — STANDARD WHEELCHAIR PLATFORM (February 6, 2009)
  • K081053 — PIVOT ASSIST (October 9, 2008)
  • K080533 — WINCO MODEL POWER SERIES LIFT CHAIR (August 11, 2008)

FDA data resources