Cleared Traditional

K240168 - N7-S

K240168 is an FDA 510(k) clearance for N7-S, manufactured by Nuga Medical Co., Ltd.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K240168 · Nuga Medical Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
234d
Days
Class 2
Risk

K240168 is an FDA 510(k) clearance for the N7-S. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Nuga Medical Co., Ltd. (Wonju-Si, KR). The FDA issued a Cleared decision on September 12, 2024 after a review of 234 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5880 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Nuga Medical Co., Ltd. devices

FDA 510(k) Submission Details - K240168

510(k) Number K240168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 115d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFB Device Classification - Class 2, Special Controls

Product Code JFB Table, Physical Therapy, Multi Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - JFB Table, Physical Therapy, Multi Function

All 15
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K240168.
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
Ceragem Automatic Thermal Massager, Model CGM-MB-1901
K202113 · Ceragem Co., Ltd. · Mar 2021