510(k) · Cleared
ClearedCeragem Automatic Thermal Massager, Model CGM-MB-1901
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceragem Co., Ltd. · JFB Table, Physical Therapy, Multi Function
Cleared on Mar 2, 2021 as substantially equivalent to K140592 (Ceragem International, Inc., 2014) after a 215-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Mar 2, 2021
- Review
- 215 days
- Class
- Class II
- Product code
- JFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K993461 (2000). 6 ancestors in all, the oldest K933443 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK993461 Quest Intersegmental Roller Traction TableIcon Intl., LLC · 2000
- 4 generations backK002390 Quantum Intersegmental Traction Table 400, 401, 400H,401HLsi Intl., Inc. · 2000
- 3 generations backK032449 Thermassage Energy Product, Model HY5000Migun Medical Instrument Co., Ltd. · 2003
- 2 generations backK040031 Ceragem-C Thermal Acupressure MassagerCeragem Co., Ltd. · 2004
- 1 generation backK140592 Ceragem Automatic Thermal MassagerCeragem International, Inc. · 2014
- This deviceK202113 Ceragem Automatic Thermal Massager, Model CGM-MB-1901Ceragem Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K993461 | Quest Intersegmental Roller Traction Table | Icon Intl., LLC | 2000 | — |
| −4 | K002390 | Quantum Intersegmental Traction Table 400, 401, 400H,401H | Lsi Intl., Inc. | 2000 | — |
| −3 | K032449 | Thermassage Energy Product, Model HY5000 | Migun Medical Instrument Co., Ltd. | 2003 | — |
| −2 | K040031 | Ceragem-C Thermal Acupressure Massager | Ceragem Co., Ltd. | 2004 | — |
| −1 | K140592 | Ceragem Automatic Thermal Massager | Ceragem International, Inc. | 2014 | — |
| 0 (this device) | K202113 | Ceragem Automatic Thermal Massager, Model CGM-MB-1901 | Ceragem Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JFB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JFB device
- #1 K240168 N7-Sscore 9.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K140592 | Ceragem Automatic Thermal MassagerSummary page 4…Multi-Function Physical Therapy Table • Regulatory Class: Class II • Product Code: JFB 4. Predicate Device Automatic Thermal Massager, Model CGM MB-1101 (K140592) by Ceragem International, Inc. 5. Description: The Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is an electric… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K140592.
How does its category compare?
All JFB devicesJFB Table, Physical Therapy, Multi Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · JFB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JFB
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JFB
No recall names JFB since 2007.
Adverse event reports per year · JFB
1in 2024
MAUDE reports naming product code JFB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 3 | 162 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the Ceragem Automatic Thermal Massager, Model CGM-MB-1901 is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the product provides topical radiant infrared heat for:
- Temporary relief of minor muscle and joint pain stiffness
- Temporary relief of minor joint pain associated with arthritis
- Temporary increase in local circulation where applied
- Relaxation of muscles
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202113: Ceragem Automatic Thermal Massager, Model CGM-MB-1901.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202113
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026