Cleared Traditional

N5-1

K153054 · Nuga Medical Co., Ltd. · Physical Medicine
Feb 2016
Decision
108d
Days
Class 2
Risk

About This 510(k) Submission

K153054 is an FDA 510(k) clearance for the N5-1, a Table, Physical Therapy, Multi Function (Class II — Special Controls, product code JFB), submitted by Nuga Medical Co., Ltd. (Wonju-Si, KR). The FDA issued a Cleared decision on February 5, 2016, 108 days after receiving the submission on October 20, 2015. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5880.

Submission Details

510(k) Number K153054 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 2015
Decision Date February 05, 2016
Days to Decision 108 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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