Cleared Traditional

K992545 - TM-300 TRACTION SYSTEM
(FDA 510(k) Clearance)

K992545 · Ito Co., Ltd. · Physical Medicine

Sep 1999

Decision

33d

Days

Class 2

Risk

K992545 is an FDA 510(k) clearance for the TM-300 TRACTION SYSTEM, a Equipment, Traction, Powered (Class II — Special Controls, product code ITH), submitted by Ito Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on September 1, 1999, 33 days after receiving the submission on July 30, 1999. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5900.

Submission Details

510(k) Number	K992545 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 1999
Decision Date	September 01, 1999
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF