Cleared Traditional

TM-400

K081247 · Ito Co., Ltd. · Physical Medicine
Aug 2008
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K081247 is an FDA 510(k) clearance for the TM-400, a Equipment, Traction, Powered (Class II — Special Controls, product code ITH), submitted by Ito Co., Ltd. (Richardson, US). The FDA issued a Cleared decision on August 25, 2008, 116 days after receiving the submission on May 1, 2008. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5900.

Submission Details

510(k) Number K081247 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 2008
Decision Date August 25, 2008
Days to Decision 116 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ITH — Equipment, Traction, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5900

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