Cleared Traditional

K925839 - TRACKMASTER
(FDA 510(k) Clearance)

K925839 · Jas Manufacturing Co., Inc. · Physical Medicine
Jun 1993
Decision
218d
Days
Class 1
Risk

K925839 is an FDA 510(k) clearance for the TRACKMASTER. This device is classified as a Treadmill, Powered (Class I — General Controls, product code IOL).

Submitted by Jas Manufacturing Co., Inc. (Carrollton, US). The FDA issued a Cleared decision on June 24, 1993, 218 days after receiving the submission on November 18, 1992.

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

Submission Details

510(k) Number K925839 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1992
Decision Date June 24, 1993
Days to Decision 218 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code IOL — Treadmill, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5380

Similar Devices — IOL Treadmill, Powered

All 42
PARKER MODEL PM
K950376 · Parker Treadmill Co., Inc. · Sep 1995
PARKER MODEL PE
K950377 · Parker Treadmill Co., Inc. · Sep 1995
RTM REHABILITATION TREADMILL, MODEL #945-200
K930261 · Biodan Medical Systems, Ltd. · May 1993
MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB
K904556 · Boston Scientific Corp · Dec 1991
TA620 TREADMILL CONTROLLER
K913518 · Siemens Burdick, Inc. · Oct 1991
T600 TREADMILL
K910867 · Siemens Burdick, Inc. · May 1991