510(k) · Cleared
ClearedN5-1
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 Feb 5, 2016 as substantially equivalent to K111329 (Nuga Medical Co., Ltd., 2011) after a 108-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Feb 5, 2016
- Review
- 108 days
- Class
- Class II
- Product code
- JFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K041200 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK041200 Thermassage Enegry Product, Model HY-7000Migun Medical Instrument Co., Ltd. · 2004
- 1 generation backK111329 NM-7000Nuga Medical Co., Ltd. · 2011
- This deviceK153054 N5-1Nuga Medical Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK240168 N7-SNuga Medical Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240168N7-SNuga Medical Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041200 | Thermassage Enegry Product, Model HY-7000 | Migun Medical Instrument Co., Ltd. | 2004 | — |
| −1 | K111329 | NM-7000 | Nuga Medical Co., Ltd. | 2011 | — |
| 0 (this device) | K153054 | N5-1 | Nuga Medical Co., Ltd. | 2016 | — |
| +1 | K240168 | N7-S | Nuga Medical Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K111329 | NM-7000Summary page 5…ification of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate device within this submission is shown as follow; 510(k) Number: K111329 Applicant: NUGA MEDICAL Co., Ltd. Common Name: Personal Heating Therapeutic Device… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240168 | N7-S | 2024 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K240168 (Nuga Medical Co., Ltd., 2024) has gone furthest, with 0 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. 2016, 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 N5-1 is to provide patients with muscle relaxation therapy by delivering heat and soothing
massage. Additionally, it provides topical heating for;
-Temporary relief of minor muscle and joint pain, and stiffness.
- Temporary relief of minor joint pain associated with arthritis.
- The temporary increase in local circulation where applied.
- Relaxation of muscle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153054: N5-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153054
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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