Cleared Traditional

K990787 - TRIO 300
(FDA 510(k) Clearance)

K990787 · Ito Co., Ltd. · Physical Medicine
Oct 1999
Decision
224d
Days
Class 2
Risk

K990787 is an FDA 510(k) clearance for the TRIO 300, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Ito Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on October 20, 1999, 224 days after receiving the submission on March 10, 1999. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K990787 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1999
Decision Date October 20, 1999
Days to Decision 224 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850