510(k) · Cleared
ClearedNM-7000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuga Medical Co., Ltd. · JFB Table, Physical Therapy, Multi Function
Cleared on Sep 6, 2011 as substantially equivalent to K041200 (Migun Medical Instrument Co., Ltd., 2004) after a 118-day review. Its family tree reaches back 1 generation to 2004. 2 later devices descend from it.
- Decided
- Sep 6, 2011
- Review
- 118 days
- Class
- Class II
- Product code
- JFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041200 (2004). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK041200 Thermassage Enegry Product, Model HY-7000Migun Medical Instrument Co., Ltd. · 2004
- This deviceK111329 NM-7000Nuga Medical Co., Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK153054 N5-1Nuga Medical Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK240168 N7-SNuga Medical Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041200 | Thermassage Enegry Product, Model HY-7000 | Migun Medical Instrument Co., Ltd. | 2004 | — |
| 0 (this device) | K111329 | NM-7000 | Nuga Medical Co., Ltd. | 2011 | — |
| +1 | K153054 | N5-1 | Nuga Medical Co., Ltd. | 2016 | — |
| +2 | K240168 | N7-S | Nuga Medical Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K041200 | Thermassage Enegry Product, Model HY-7000Summary page 1…Manufacturer .MIGUN MEDICAL INSTRUMENT Co., Ltd. Device .HY-7000 510(k) Number :K041 200 (Decision Date - Jun. 17. 2004) 4. Classifications Names & Citations: 21 CFR89O.5880, 21 CFR89O.5500, 21 CFR89O.5660,… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153054 | N5-1 | 2016 | 1 |
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?
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. 2011, 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 NM-7000 is to provide patients with muscle relaxation therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for;
- Temporary relief of minor muscle and joint pain, and stiffness
- The temporary relief of minor joint pain associated with arthritis
- The temporary increase in local circulation where applied
- Relaxation of muscles
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111329: NM-7000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111329
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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