510(k) · Cleared
ClearedThermassage Energy Product, Model HY5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Migun Medical Instrument Co., Ltd. · JFB Table, Physical Therapy, Multi Function
Cleared on Oct 22, 2003 as substantially equivalent to K002390 (Lsi Intl., Inc., 2000) and 1 other predicate after a 75-day review. Its family tree reaches back 2 generations to 2000. 11 later devices descend from it.
- Decided
- Oct 22, 2003
- Review
- 75 days
- Class
- Class II
- Product code
- JFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K993461 (2000). 3 ancestors in all, the oldest K933443 (1994). 11 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK993461 Quest Intersegmental Roller Traction TableIcon Intl., LLC · 2000
- 1 generation backK002390 Quantum Intersegmental Traction Table 400, 401, 400H,401HLsi Intl., Inc. · 2000
- This deviceK032449 Thermassage Energy Product, Model HY5000Migun Medical Instrument Co., Ltd. · 2003
- Descendant · cites it directly · 10 of its ownK040031 Ceragem-C Thermal Acupressure MassagerCeragem Co., Ltd. · 2004
- Descendant · 2 generations on · 4 of its ownK140592 Ceragem Automatic Thermal MassagerCeragem International, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK062476 Ceragem RH1 Automatic Thermal MassagerCeragem International, Inc. · 2006
- Descendant · 3 generations on · 2 of its ownK202937 Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702Ceragem Co., Ltd. · 2021
- Descendant · 4 generations on · 1 of its ownK220572 Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd. · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K040031Ceragem-C Thermal Acupressure MassagerCeragem Co., Ltd. · 2004 · cites it directly10descendants
- K140592Ceragem Automatic Thermal MassagerCeragem International, Inc. · 2014 · 2 generations on4descendants
- K062476Ceragem RH1 Automatic Thermal MassagerCeragem International, Inc. · 2006 · 2 generations on3descendants
- K202937Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702Ceragem Co., Ltd. · 2021 · 3 generations on2descendants
- K220572Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd. · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993461 | Quest Intersegmental Roller Traction Table | Icon Intl., LLC | 2000 | — |
| −1 | K002390 | Quantum Intersegmental Traction Table 400, 401, 400H,401H | Lsi Intl., Inc. | 2000 | — |
| 0 (this device) | K032449 | Thermassage Energy Product, Model HY5000 | Migun Medical Instrument Co., Ltd. | 2003 | — |
| +1 | K040031 | Ceragem-C Thermal Acupressure Massager | Ceragem Co., Ltd. | 2004 | — |
| +2 | K140592 | Ceragem Automatic Thermal Massager | Ceragem International, Inc. | 2014 | — |
| +2 | K062476 | Ceragem RH1 Automatic Thermal Massager | Ceragem International, Inc. | 2006 | — |
| +3 | K202937 | Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 | Ceragem Co., Ltd. | 2021 | — |
| +4 | K220572 | Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 | Ceragem Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K002390 | Quantum Intersegmental Traction Table 400, 401, 400H,401HSummary page 2…le Classification Name Multi-Functional Physical Therapy Table Predicate Devices 1. LSI International’s Quantum Intersegmental Roller Traction Table (K002390) 2. Williams Healthcare’s Combi 2.5 Intersegemental Traction Table (K933443) Intended Use The intended use of the Migun Mode… | 2000 |
| * | K933443 | Combi 2.5 Intersegmental Traction TableSummary page 2…Predicate Devices 1. LSI International’s Quantum Intersegmental Roller Traction Table (K002390) 2. Williams Healthcare’s Combi 2.5 Intersegemental Traction Table (K933443) Intended Use The intended use of the Migun Model HY5000 Thermassage Energy Product is to provide patients with muscle relaxatio… | 1994 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040031 | Ceragem-C Thermal Acupressure Massager | 2004 | 10 |
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 3 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K040031 (Ceragem Co., Ltd., 2004) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K002390.
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 Migun Model HY5000 Thermassage Energy Product is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for;
o temporary relief of minor muscle and joint pain, and stiffness
o the temporary relief of minor joint pain associated with arthritis
o the temporary increase in local circulation where applied
o relaxation of muscles
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032449: Thermassage Energy Product, Model HY5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032449
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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