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510(k) K123834

EASYSTAND BANTAM MEDIUM by Altimate Medical, Inc. — Product Code INO

K123834 is an FDA 510(k) premarket notification submitted by Altimate Medical, Inc. for the device "EASYSTAND BANTAM MEDIUM". The FDA issued a decision of Substantially Equivalent on August 13, 2013. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110. Altimate Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2013
Date Received
December 13, 2012
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 Altimate Medical, Inc.

  • K091242 — BANTAM (July 6, 2009)

Other clearances for product code INO

  • K131909 — DALTON LIFT CHAIR (February 24, 2014)
  • 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)
  • K091242 — BANTAM (July 6, 2009)
  • K091727 — MEDICAL TREATMENT CHAIR, T400, T500,T600 (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)
  • K071793 — CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR (August 3, 2007)

FDA data resources