Cleared Traditional

MODEL K210 AND K211 FLUIDOTHERAPY UNITS

K871802 · Henley Intl. · Physical Medicine
Sep 1987
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K871802 is an FDA 510(k) clearance for the MODEL K210 AND K211 FLUIDOTHERAPY UNITS, a Unit, Fluidotherapy (Class II — Special Controls, product code LSB), submitted by Henley Intl. (Houston, US). The FDA issued a Cleared decision on September 4, 1987, 119 days after receiving the submission on May 8, 1987. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5100.

Submission Details

510(k) Number K871802 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1987
Decision Date September 04, 1987
Days to Decision 119 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