Cleared Traditional

K202113 - Ceragem Automatic Thermal Massager

K202113 is an FDA 510(k) clearance for Ceragem Automatic Thermal Massager, manufactured by Ceragem Co., Ltd.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K202113 · Ceragem Co., Ltd. · Physical Medicine device
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Mar 2021
Decision
215d
Days
Class 2
Risk

K202113 is an FDA 510(k) clearance for the Ceragem Automatic Thermal Massager, Model CGM-MB-1901. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Ceragem Co., Ltd. (Chennan-Si, KR). The FDA issued a Cleared decision on March 2, 2021 after a review of 215 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 Ceragem Co., Ltd. devices

FDA 510(k) Submission Details - K202113

510(k) Number K202113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2020
Decision Date March 02, 2021
Days to Decision 215 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
100d slower than avg
Panel avg: 115d · This submission: 215d
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 Consultant

LK Consulting Group USA, Inc.
Priscilla Chung

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 15
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K202113.
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
TRUE-TRAC, STRATUS
K926316 · Henley Intl. · Mar 1993
745-M (MAGNUM)
K922980 · Tri W-G, Inc. · Jul 1992
IST-200 INTERSEGMENTAL TRACTION TABLE
K900304 · Chattanooga Group, Inc. · Apr 1990