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510(k) K897179

ORBITER(TM) TREADMILL by Lee-Meredith Industries, Inc. — Product Code IOL

K897179 is an FDA 510(k) premarket notification submitted by Lee-Meredith Industries, Inc. for the device "ORBITER(TM) TREADMILL". The FDA issued a decision of Substantially Equivalent on February 15, 1990. 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
February 15, 1990
Date Received
December 28, 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)
  • K895104 — AQUATREX UNDERWATER TREADMILL SYSTEM (December 4, 1989)
  • K893032 — PACER R 9 TREADMILL (July 27, 1989)

FDA data resources