510(k) · Cleared
ClearedCeragem Automatic Thermal Massager (CGM MB-2401)
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 11, 2025 after a 162-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 11, 2025
- Review
- 162 days
- Class
- Class II
- Product code
- JFB
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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. 2025, 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-2401 is designed to provide muscle relaxation therapy by delivering heat and soothing massage to affected areas. 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…
Read the full statement (111 words)
The intended use of the Ceragem Automatic Thermal Massager, Model CGM MB-2401 is designed to provide muscle relaxation therapy by delivering heat and soothing massage to affected areas.
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
The aircell leg massager is designed to provide temporary relief of minor muscle aches and pains and a temporary increase in blood circulation to the treated areas. The aircell leg massager stimulates kneading and stroking of tissues by using an inflatable garment.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K250266 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250266: Ceragem Automatic Thermal Massager (CGM MB-2401).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250266
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026