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510(k) K912175

ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE by Isotechnologies, Inc. — Product Code INK

K912175 is an FDA 510(k) premarket notification submitted by Isotechnologies, Inc. for the device "ISOTECHNOLOGIES LIFTSTATION & LIFTWORKS SOFTWARE". The FDA issued a decision of Substantially Equivalent on June 7, 1991. The device falls under product code INK (Stretcher, Wheeled, Powered), a Class II device regulated under 21 CFR 890.3690. Isotechnologies, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1991
Date Received
May 16, 1991
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

Other clearances by Isotechnologies, Inc.

  • K933063 — ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA (January 27, 1994)
  • K854621 — ISOSTATION KNEE MACHINE (K-100) (March 7, 1986)
  • K844060 — ISOSTATION ANKLE/SUBTALAR MACHINE A-100 (November 23, 1984)
  • K842296 — ISOSTATION LOWER BACK MACHINE (June 22, 1984)
  • K841849 — ISOSTATION SHOULDER MACHINE (May 14, 1984)

Other clearances for product code INK

  • K152056 — Winco Model S550 Stretchair (April 11, 2016)
  • K140095 — PRIME ZOOM STRETCHER (May 20, 2014)
  • K112502 — PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 (September 19, 2011)
  • K110671 — WINCO STRETCHAIR (April 22, 2011)
  • K102236 — HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P (November 18, 2010)
  • K091043 — POWER DRIVE CHAIR, MODEL: TMM6 (May 11, 2009)
  • 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)
  • K844711 — MODELS 134, 135 & 136 TRANSFER CART/TABLE (March 5, 1985)

FDA data resources