Cleared Traditional

EXERCISE BICYCLE

K926287 · Henley Intl. · Physical Medicine
Mar 1994
Decision
463d
Days
Class 2
Risk

About This 510(k) Submission

K926287 is an FDA 510(k) clearance for the EXERCISE BICYCLE, a Exerciser, Measuring (Class II — Special Controls, product code ISD), submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on March 22, 1994, 463 days after receiving the submission on December 14, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5360.

Submission Details

510(k) Number K926287 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 1992
Decision Date March 22, 1994
Days to Decision 463 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code ISD — Exerciser, Measuring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5360

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