Cleared Traditional

HYDRA FITNESS MODEL 311 TOTAL POWER

K926314 · Henley Intl. · Physical Medicine
Mar 1994
Decision
458d
Days
Class 2
Risk

About This 510(k) Submission

K926314 is an FDA 510(k) clearance for the HYDRA FITNESS MODEL 311 TOTAL POWER, 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 18, 1994, 458 days after receiving the submission on December 15, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5360.

Submission Details

510(k) Number K926314 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 1992
Decision Date March 18, 1994
Days to Decision 458 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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