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510(k) K890793

STARTRAC by Unisen, Inc. — Product Code IOL

K890793 is an FDA 510(k) premarket notification submitted by Unisen, Inc. for the device "STARTRAC". The FDA issued a decision of Substantially Equivalent on March 16, 1989. The device falls under product code IOL (Treadmill, Powered), a Class I device regulated under 21 CFR 890.5380.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1989
Date Received
February 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Treadmill, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type

Other clearances for product code IOL

  • K950376 — PARKER MODEL PM (September 6, 1995)
  • K950377 — PARKER MODEL PE (September 6, 1995)
  • K925839 — TRACKMASTER (June 24, 1993)
  • K930261 — RTM REHABILITATION TREADMILL, MODEL #945-200 (May 26, 1993)
  • K904556 — MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB (December 18, 1991)
  • K913518 — TA620 TREADMILL CONTROLLER (October 24, 1991)
  • K910867 — T600 TREADMILL (May 31, 1991)
  • K911751 — MEDTRACK TREADMILL (May 29, 1991)
  • K897179 — ORBITER(TM) TREADMILL (February 15, 1990)
  • K895104 — AQUATREX UNDERWATER TREADMILL SYSTEM (December 4, 1989)

FDA data resources