Cleared Traditional

N7-S

K240168 · Nuga Medical Co., Ltd. · Physical Medicine
Sep 2024
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K240168 is an FDA 510(k) clearance for the N7-S, 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 September 12, 2024, 234 days after receiving the submission on January 22, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5880.

Submission Details

510(k) Number K240168 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2024
Decision Date September 12, 2024
Days to Decision 234 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

Similar Devices — JFB Table, Physical Therapy, Multi Function

All 65
Ceragem Automatic Thermal Massager (CGM MB-2401)
K250266 · Ceragem Co., Ltd. · Jul 2025
AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
K241193 · Marzzan Lucas Jorge · Jan 2025
Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)
K243644 · Ceragem Co., Ltd. · Jan 2025
Ceragem Automatic Thermal Massager (CGM-MB-1902)
K243355 · Ceragem Co., Ltd. · Nov 2024
Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
K220572 · Ceragem Co., Ltd. · Jun 2022
Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702
K202937 · Ceragem Co., Ltd. · Mar 2021