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510(k) K953342

TMR48 by Pride Health Care, Inc. — Product Code INO

K953342 is an FDA 510(k) premarket notification submitted by Pride Health Care, Inc. for the device "TMR48". The FDA issued a decision of Substantially Equivalent on September 8, 1995. The device falls under product code INO (Chair, Positioning, Electric), a Class II device regulated under 21 CFR 890.3110. Pride Health Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1995
Date Received
July 11, 1995
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 Pride Health Care, Inc.

  • K945936 — JAZZY (May 28, 1996)
  • K944940 — EURO SC500 (February 12, 1996)
  • K944277 — DYNAMO (December 28, 1994)
  • K944939 — CELEBRITY XL SC445 (November 7, 1994)
  • K931231 — SIDEKICK II (May 5, 1994)
  • K930952 — PRIDE LEGEND SC-340 (March 28, 1994)
  • K926499 — SHUTTLE SC-140 (March 28, 1994)
  • K926296 — CELEBRITY SC400 (March 28, 1994)
  • K926295 — LEGEND SC 300 (March 28, 1994)
  • K930953 — CELEBRITY SC440 (March 28, 1994)

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