Cleared Traditional

MODEL T11 FLUIDOTHERAPY UNIT

K896817 · Henley Intl. · Physical Medicine
Jan 1991
Decision
410d
Days
Class 2
Risk

About This 510(k) Submission

K896817 is an FDA 510(k) clearance for the MODEL T11 FLUIDOTHERAPY UNIT, a Unit, Fluidotherapy (Class II — Special Controls, product code LSB), submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on January 18, 1991, 410 days after receiving the submission on December 4, 1989. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5100.

Submission Details

510(k) Number K896817 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1989
Decision Date January 18, 1991
Days to Decision 410 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code LSB — Unit, Fluidotherapy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5100