510(k) · Cleared
ClearedCeragem Automatic Thermal Massager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceragem International, Inc. · JFB Table, Physical Therapy, Multi Function
Cleared on Dec 17, 2014 as substantially equivalent to K040031 (Ceragem Co., Ltd., 2004) after a 285-day review. Its family tree reaches back 4 generations to 2000. 4 later devices descend from it.
- Decided
- Dec 17, 2014
- Review
- 285 days
- Class
- Class II
- Product code
- JFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K993461 (2000). 5 ancestors in all, the oldest K933443 (1994). 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK993461 Quest Intersegmental Roller Traction TableIcon Intl., LLC · 2000
- 3 generations backK002390 Quantum Intersegmental Traction Table 400, 401, 400H,401HLsi Intl., Inc. · 2000
- 2 generations backK032449 Thermassage Energy Product, Model HY5000Migun Medical Instrument Co., Ltd. · 2003
- 1 generation backK040031 Ceragem-C Thermal Acupressure MassagerCeragem Co., Ltd. · 2004
- This deviceK140592 Ceragem Automatic Thermal MassagerCeragem International, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK202937 Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702Ceragem Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK220572 Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK240168 N7-SNuga Medical Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK202113 Ceragem Automatic Thermal Massager, Model CGM-MB-1901Ceragem Co., Ltd. · 2021
Most influential descendants
Showing 4 of 4 · See all- K202937Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702Ceragem Co., Ltd. · 2021 · cites it directly2descendants
- K220572Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd. · 2022 · 2 generations on1descendant
- K240168N7-SNuga Medical Co., Ltd. · 2024 · 3 generations on0descendants
- K202113Ceragem Automatic Thermal Massager, Model CGM-MB-1901Ceragem Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993461 | Quest Intersegmental Roller Traction Table | Icon Intl., LLC | 2000 | — |
| −3 | K002390 | Quantum Intersegmental Traction Table 400, 401, 400H,401H | Lsi Intl., Inc. | 2000 | — |
| −2 | K032449 | Thermassage Energy Product, Model HY5000 | Migun Medical Instrument Co., Ltd. | 2003 | — |
| −1 | K040031 | Ceragem-C Thermal Acupressure Massager | Ceragem Co., Ltd. | 2004 | — |
| 0 (this device) | K140592 | Ceragem Automatic Thermal Massager | Ceragem International, Inc. | 2014 | — |
| +1 | K202937 | Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 | Ceragem Co., Ltd. | 2021 | — |
| +2 | K220572 | Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 | Ceragem Co., Ltd. | 2022 | — |
| +3 | K240168 | N7-S | Nuga Medical Co., Ltd. | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K040031 | Ceragem-C Thermal Acupressure MassagerSummary page 5…807.92(a)(3) Manufacturer Brand Name 510(k) Number Ceragem International, Inc. CERAGEM-C Thermal Massager K040031 Device Description 807.92(a)(4) This device is comprised o… | 2004 |
What descends from it? (4)
2 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 14 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K202937 (Ceragem Co., Ltd., 2021) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K040031.
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. 2014, 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® Thermal Massager Model CGM-MB-1101 Automatic Thermal Massager 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/K140592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140592: Ceragem Automatic Thermal Massager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140592
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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