Cleared Traditional

K913518 - TA620 TREADMILL CONTROLLER
(FDA 510(k) Clearance)

K913518 · Siemens Burdick, Inc. · Physical Medicine device

Oct 1991

Decision

78d

Days

Class 1

Risk

K913518 is an FDA 510(k) clearance for the TA620 TREADMILL CONTROLLER. This device is classified as a Treadmill, Powered (Class I - General Controls, product code IOL).

Submitted by Siemens Burdick, Inc. (Miltoon, US). The FDA issued a Cleared decision on October 24, 1991, 78 days after receiving the submission on August 7, 1991.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number	K913518 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 07, 1991
Decision Date	October 24, 1991
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement