N7-S

FDA 510(k) K240168 · Nuga Medical Co., Ltd.

Substantially Equivalent

510(k) numberK240168

Submission

Device name
N7-S
Applicant
Nuga Medical Co., Ltd.
Wonju-Si, KR
Received
January 22, 2024
Decision date
September 12, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JFB – Table, Physical Therapy, Multi Function
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5880
Specialty
Physical Medicine

Other 510(k)s with product code JFB

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K250266Ceragem Automatic Thermal Massager (CGM MB-2401)JFB · Traditional Ceragem Co., Ltd.07/11/2025SE
K241193AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)JFB · Traditional Marzzan Lucas Jorge01/31/2025SE
K243644Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)JFB · Special Ceragem Co., Ltd.01/08/2025SE
K243355Ceragem Automatic Thermal Massager (CGM-MB-1902)JFB · Special Ceragem Co., Ltd.11/27/2024SE
K220572Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702JFB · Traditional Ceragem Co., Ltd.06/17/2022SE
K202937Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702JFB · Traditional Ceragem Co., Ltd.03/18/2021SE
K202113Ceragem Automatic Thermal Massager, Model CGM-MB-1901JFB · Traditional Ceragem Co., Ltd.03/02/2021SE
K153054N5-1JFB · Traditional Nuga Medical Co., Ltd.02/05/2016SE
K140592Ceragem Automatic Thermal MassagerJFB · Traditional Ceragem International, Inc.12/17/2014SE
K111588LEGACY-500JFB · Traditional Mt Tables, LLC10/26/2012SE

More from Mt Tables, LLC

510(k)DeviceDecision
K153054N5-1JFB · Traditional 02/05/2016SE
K111329NM-7000JFB · Traditional 09/06/2011SE

Questions and answers

When was N7-S cleared by the FDA?

N7-S (K240168) received a 510(k) decision of Substantially Equivalent on September 12, 2024, 234 days after the submission was received.

What is the product code of K240168?

The FDA product code is JFB – Table, Physical Therapy, Multi Function, a Class II (moderate risk) device regulated under 21 CFR 890.5880.