510(k) · Cleared
ClearedCeragem-C Thermal Acupressure Massager
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 Jul 28, 2004 as substantially equivalent to K032449 (Migun Medical Instrument Co., Ltd., 2003) after a 202-day review. Its family tree reaches back 3 generations to 2000. 10 later devices descend from it.
- Decided
- Jul 28, 2004
- Review
- 202 days
- Class
- Class II
- Product code
- JFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K993461 (2000). 4 ancestors in all, the oldest K933443 (1994). 10 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK993461 Quest Intersegmental Roller Traction TableIcon Intl., LLC · 2000
- 2 generations backK002390 Quantum Intersegmental Traction Table 400, 401, 400H,401HLsi Intl., Inc. · 2000
- 1 generation backK032449 Thermassage Energy Product, Model HY5000Migun Medical Instrument Co., Ltd. · 2003
- This deviceK040031 Ceragem-C Thermal Acupressure MassagerCeragem Co., Ltd. · 2004
- Descendant · cites it directly · 4 of its ownK140592 Ceragem Automatic Thermal MassagerCeragem International, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK062476 Ceragem RH1 Automatic Thermal MassagerCeragem International, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK202937 Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702Ceragem Co., Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK220572 Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK080554 Inarex, Model 2D-LXInarex Corporation · 2008
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K140592Ceragem Automatic Thermal MassagerCeragem International, Inc. · 2014 · cites it directly4descendants
- K062476Ceragem RH1 Automatic Thermal MassagerCeragem International, Inc. · 2006 · cites it directly3descendants
- K202937Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702Ceragem Co., Ltd. · 2021 · 2 generations on2descendants
- K220572Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd. · 2022 · 3 generations on1descendant
- K080554Inarex, Model 2D-LXInarex Corporation · 2008 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993461 | Quest Intersegmental Roller Traction Table | Icon Intl., LLC | 2000 | — |
| −2 | K002390 | Quantum Intersegmental Traction Table 400, 401, 400H,401H | Lsi Intl., Inc. | 2000 | — |
| −1 | K032449 | Thermassage Energy Product, Model HY5000 | Migun Medical Instrument Co., Ltd. | 2003 | — |
| 0 (this device) | K040031 | Ceragem-C Thermal Acupressure Massager | Ceragem Co., Ltd. | 2004 | — |
| +1 | K140592 | Ceragem Automatic Thermal Massager | Ceragem International, Inc. | 2014 | — |
| +1 | K062476 | Ceragem RH1 Automatic Thermal Massager | Ceragem International, Inc. | 2006 | — |
| +2 | K202937 | Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 | Ceragem Co., Ltd. | 2021 | — |
| +3 | K220572 | Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 | Ceragem Co., Ltd. | 2022 | — |
| +1 | K080554 | Inarex, Model 2D-LX | Inarex Corporation | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K032449 | Thermassage Energy Product, Model HY5000Summary page 1…ssification Name: Multi-Function Therapy Table (Class II), 21 CFR 890.5880 Predicate Device: Migun HY5000 Thermassage Energy Product (K032449) Migun Medical Instrument Co., Ltd. Product Description: The CERAGEM-C Thermal Massager is… | 2003 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K140592 (Ceragem International, Inc., 2014) has gone furthest, with 4 descendants of its own.
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.
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-C Thermal Massager is to provide muscle relaxation therapy by delivering heat and soothing massage. Additionally, the Ceragem-C Thermal Massager provides radiant infrared heat for;
0 temporary relief of minor muscle and joint pain, and stiffness
0 the temporary relief of minor joint pain associated with arthritis
0 the temporary increase in local circulation where applied
0 relaxation of muscles
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040031: Ceragem-C Thermal Acupressure Massager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040031
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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