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510(k) K926287

EXERCISE BICYCLE by Henley Intl. — Product Code ISD

K926287 is an FDA 510(k) premarket notification submitted by Henley Intl. for the device "EXERCISE BICYCLE". The FDA issued a decision of Substantially Equivalent on March 22, 1994. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360. Henley Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1994
Date Received
December 14, 1992
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 Henley Intl.

  • K943449 — NEUROLOGICAL DIAGNOSTIC DEVICES (November 15, 1995)
  • K926279 — UPPER BODY EXERCISER (May 5, 1994)
  • K926278 — STAIR CLIMBER (May 5, 1994)
  • K926314 — HYDRA FITNESS MODEL 311 TOTAL POWER (March 18, 1994)
  • K926313 — COMPUTERIZED TESTING AND EXERCISE SYSTEMS (February 4, 1994)
  • K915864 — MONOTRODE CUTANEOUS ELECTRODE (July 21, 1993)
  • K922036 — SONOPULS 591 (June 29, 1993)
  • K926316 — TRUE-TRAC, STRATUS (March 24, 1993)
  • K920983 — SONOPULS 590 (March 9, 1993)
  • K922020 — ENDOMED 582 (September 22, 1992)

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