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510(k) K791866

STANDARD HEALTH BIKE MODEL 019 by Battle Creek Equipment Co. — Product Code ISD

K791866 is an FDA 510(k) premarket notification submitted by Battle Creek Equipment Co. for the device "STANDARD HEALTH BIKE MODEL 019". The FDA issued a decision of Substantially Equivalent on October 4, 1979. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360. Battle Creek Equipment Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1979
Date Received
September 21, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Measuring
Device Class
Class II
Regulation Number
890.5360
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)
  • K854148 — BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL (December 17, 1985)
  • K851237 — THERMOPHORE ELECTRIC FOMENTATION UNIT (July 29, 1985)
  • K840280 — ROAD RUNNER ELECTRIC TREADMILL (February 4, 1984)

Other clearances for product code ISD

  • K202979 — MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Do (December 21, 2020)
  • K183296 — REAL Immersive System (March 18, 2019)
  • K143512 — ActiSpec Activity Monitor (August 26, 2015)
  • K112121 — ERGOSELECT/GE (October 31, 2012)
  • K080545 — ACTITRAINER (July 24, 2008)
  • K053078 — ERGOSELECT 100 K/P, ERGOSELECT 200 K/P (April 27, 2006)
  • K990866 — QUINTON MEDTRACK CR PLUS TREADMILL (April 29, 1999)
  • K990813 — REHCOR (April 12, 1999)
  • K962855 — ULE-2, MULE-2, HAND ACCESSORY KIT (December 11, 1996)
  • K952163 — DAVID BACK CLINIC SYSTEM (August 12, 1996)

FDA data resources