Cleared Traditional

COMPUTERIZED TESTING AND EXERCISE SYSTEMS

K926313 · Henley Intl. · Physical Medicine

Feb 1994

Decision

416d

Days

Class 1

Risk

About This 510(k) Submission

K926313 is an FDA 510(k) clearance for the COMPUTERIZED TESTING AND EXERCISE SYSTEMS, a Exerciser, Powered (Class I — General Controls, product code BXB), submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on February 4, 1994, 416 days after receiving the submission on December 15, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number	K926313 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 1992
Decision Date	February 04, 1994
Days to Decision	416 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement