Cleared Special

K243644 - Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243644 · Ceragem Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
43d
Days
Class 2
Risk

K243644 is an FDA 510(k) clearance for the Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302). Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Ceragem Co., Ltd. (Cheonan-Si, KR). The FDA issued a Cleared decision on January 8, 2025 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5880 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ceragem Co., Ltd. devices

Submission Details

510(k) Number K243644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2024
Decision Date January 08, 2025
Days to Decision 43 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Consultant

Provision Consulting Group, Inc.
Joyce Kwon

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JFB Table, Physical Therapy, Multi Function

All 65
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K243644.
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-1902)
K243355 · Ceragem Co., Ltd. · Nov 2024
N7-S
K240168 · Nuga Medical Co., Ltd. · Sep 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