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510(k) K895104

AQUATREX UNDERWATER TREADMILL SYSTEM by Edmonds Medical Systems — Product Code IOL

K895104 is an FDA 510(k) premarket notification submitted by Edmonds Medical Systems for the device "AQUATREX UNDERWATER TREADMILL SYSTEM". The FDA issued a decision of Substantially Equivalent on December 4, 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
December 4, 1989
Date Received
August 15, 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

  • K950377 — PARKER MODEL PE (September 6, 1995)
  • K950376 — PARKER MODEL PM (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)
  • K893032 — PACER R 9 TREADMILL (July 27, 1989)

FDA data resources