Cleared Traditional

K926316 - TRUE-TRAC, STRATUS
(FDA 510(k) Clearance)

K926316 · Henley Intl. · Physical Medicine

Mar 1993

Decision

99d

Days

Class 2

Risk

K926316 is an FDA 510(k) clearance for the TRUE-TRAC, STRATUS, a Table, Physical Therapy, Multi Function (Class II — Special Controls, product code JFB), submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on March 24, 1993, 99 days after receiving the submission on December 15, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5880.

Submission Details

510(k) Number	K926316 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 1992
Decision Date	March 24, 1993
Days to Decision	99 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement