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510(k) K060212

MERITS MODEL E SERIES LIFT CHAIRS by Merits Health Products Co., Ltd. — Product Code INO

K060212 is an FDA 510(k) premarket notification submitted by Merits Health Products Co., Ltd. for the device "MERITS MODEL E SERIES LIFT CHAIRS". The FDA issued a decision of Substantially Equivalent on March 7, 2006. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110. Merits Health Products Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2006
Date Received
January 27, 2006
Clearance Type
Abbreviated
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 Merits Health Products Co., Ltd.

  • K220529 — Merits P335 Powered Wheelchair (March 18, 2022)
  • K142912 — Merits Yoga Power Scooter, S542 (June 23, 2015)
  • K142162 — MERITS TRANSFORMER POWER SCOOTER, S941 (May 1, 2015)
  • K122357 — MERITS MODEL P322FWD POWERED WHEELCHAIR (January 9, 2013)
  • K113577 — MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR (May 8, 2012)
  • K092859 — MERITS MODEL N SERIES NEBULIZER COMPRESSORS (July 2, 2010)
  • K091716 — MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY (April 2, 2010)
  • K073110 — MERITS E600 SERIES STAIR LIFT (February 6, 2008)
  • K073513 — MERITS E700 PORCE LIFT (January 14, 2008)
  • K053490 — MERITS HEALTH PRODUCTS PORTABLE NEBULIZER (July 24, 2006)

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