Cleared Traditional

E-Z FLEX

K953456 · Fluid Motion Biotechnologies, Inc. · Physical Medicine

Jan 1996

Decision

191d

Days

Class 1

Risk

About This 510(k) Submission

K953456 is an FDA 510(k) clearance for the E-Z FLEX, a Exerciser, Powered (Class I — General Controls, product code BXB), submitted by Fluid Motion Biotechnologies, Inc. (Great Neck, US). The FDA issued a Cleared decision on January 26, 1996, 191 days after receiving the submission on July 19, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number	K953456 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 1995
Decision Date	January 26, 1996
Days to Decision	191 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF