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510(k) K854148

BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL by Battle Creek Equipment Co. — Product Code IOL

K854148 is an FDA 510(k) premarket notification submitted by Battle Creek Equipment Co. for the device "BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL". The FDA issued a decision of Substantially Equivalent on December 17, 1985. The device falls under product code IOL (Treadmill, Powered), a Class I device regulated under 21 CFR 890.5380. Battle Creek Equipment Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1985
Date Received
October 11, 1985
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 by Battle Creek Equipment Co.

  • K882264 — BATTLE CREEK PILLOW (August 9, 1988)
  • K863884 — PULSESTAR EXERCISE BIKE (October 23, 1986)
  • K854147 — BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL (December 27, 1985)
  • K851237 — THERMOPHORE ELECTRIC FOMENTATION UNIT (July 29, 1985)
  • K840280 — ROAD RUNNER ELECTRIC TREADMILL (February 4, 1984)
  • K791866 — STANDARD HEALTH BIKE MODEL 019 (October 4, 1979)

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