Cleared Traditional

NM-7000

K111329 · Nuga Medical Co., Ltd. · Physical Medicine
Sep 2011
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K111329 is an FDA 510(k) clearance for the NM-7000, a Table, Physical Therapy, Multi Function (Class II — Special Controls, product code JFB), submitted by Nuga Medical Co., Ltd. (Echo, US). The FDA issued a Cleared decision on September 6, 2011, 118 days after receiving the submission on May 11, 2011. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5880.

Submission Details

510(k) Number K111329 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2011
Decision Date September 06, 2011
Days to Decision 118 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code JFB — Table, Physical Therapy, Multi Function
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5880

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