510(k) · Cleared
ClearedThermassage Enegry Product, Model HY-7000
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 Jun 17, 2004 after a 41-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jun 17, 2004
- Review
- 41 days
- Class
- Class II
- Product code
- JFB
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK041200 Thermassage Enegry Product, Model HY-7000Migun Medical Instrument Co., Ltd. · 2004
- Descendant · cites it directly · 2 of its ownK111329 NM-7000Nuga Medical Co., Ltd. · 2011
- Descendant · 2 generations on · 1 of its ownK153054 N5-1Nuga Medical Co., Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK240168 N7-SNuga Medical Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK111941 Choyang Thermal MassagerChoyang Medical Instrument Co., Ltd. · 2012
Most influential descendants
Showing 4 of 4 · See all- K111329NM-7000Nuga Medical Co., Ltd. · 2011 · cites it directly2descendants
- K153054N5-1Nuga Medical Co., Ltd. · 2016 · 2 generations on1descendant
- K240168N7-SNuga Medical Co., Ltd. · 2024 · 3 generations on0descendants
- K111941Choyang Thermal MassagerChoyang Medical Instrument Co., Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041200 | Thermassage Enegry Product, Model HY-7000 | Migun Medical Instrument Co., Ltd. | 2004 | — |
| +1 | K111329 | NM-7000 | Nuga Medical Co., Ltd. | 2011 | — |
| +2 | K153054 | N5-1 | Nuga Medical Co., Ltd. | 2016 | — |
| +3 | K240168 | N7-S | Nuga Medical Co., Ltd. | 2024 | — |
| +1 | K111941 | Choyang Thermal Massager | Choyang Medical Instrument Co., Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2024 | 1 | 0 |
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? (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?
- Of its descendants, K111329 (Nuga Medical Co., Ltd., 2011) has gone furthest, with 2 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 Migun Model HY-7000 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 510(k) statement.
https://510kreport.com/device/K041200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041200: Thermassage Enegry Product, Model HY-7000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041200
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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