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510(k) K091043

POWER DRIVE CHAIR, MODEL: TMM6 by Transmotion Medical, Inc. — Product Code INK

K091043 is an FDA 510(k) premarket notification submitted by Transmotion Medical, Inc. for the device "POWER DRIVE CHAIR, MODEL: TMM6". The FDA issued a decision of Substantially Equivalent on May 11, 2009. The device falls under product code INK (Stretcher, Wheeled, Powered), a Class II device regulated under 21 CFR 890.3690.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2009
Date Received
April 13, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stretcher, Wheeled, Powered
Device Class
Class II
Regulation Number
890.3690
Review Panel
PM
Submission Type

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  • K102236 — HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P (November 18, 2010)
  • K051861 — THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777 (September 28, 2005)
  • K041924 — HAUSTED POWERTRAN SERIES STRETCHER (September 9, 2004)
  • K022309 — STRYKER POWERED WHEELED STRETCHER (November 8, 2002)
  • K912175 — ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE (June 7, 1991)
  • K844711 — MODELS 134, 135 & 136 TRANSFER CART/TABLE (March 5, 1985)

FDA data resources