510(k) · Cleared
ClearedN7-S
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 12, 2024 as substantially equivalent to K220572 (Ceragem Co., Ltd., 2022) and 1 other predicate after a 234-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Sep 12, 2024
- Review
- 234 days
- Class
- Class II
- Product code
- JFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K993461 (2000). 11 ancestors in all, the oldest K933443 (1994). No later device cites it as a predicate yet.
- Root · 7 generations backK993461 Quest Intersegmental Roller Traction TableIcon Intl., LLC · 2000
- 6 generations backK002390 Quantum Intersegmental Traction Table 400, 401, 400H,401HLsi Intl., Inc. · 2000
- 5 generations backK032449 Thermassage Energy Product, Model HY5000Migun Medical Instrument Co., Ltd. · 2003
- 4 generations backK040031 Ceragem-C Thermal Acupressure MassagerCeragem Co., Ltd. · 2004
- 3 generations backK140592 Ceragem Automatic Thermal MassagerCeragem International, Inc. · 2014
- 2 generations backK202937 Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702Ceragem Co., Ltd. · 2021
- 1 generation backK220572 Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Ceragem Co., Ltd. · 2022
- This deviceK240168 N7-SNuga Medical Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K993461 | Quest Intersegmental Roller Traction Table | Icon Intl., LLC | 2000 | — |
| −6 | K002390 | Quantum Intersegmental Traction Table 400, 401, 400H,401H | Lsi Intl., Inc. | 2000 | — |
| −5 | K032449 | Thermassage Energy Product, Model HY5000 | Migun Medical Instrument Co., Ltd. | 2003 | — |
| −4 | K040031 | Ceragem-C Thermal Acupressure Massager | Ceragem Co., Ltd. | 2004 | — |
| −3 | K140592 | Ceragem Automatic Thermal Massager | Ceragem International, Inc. | 2014 | — |
| −2 | K202937 | Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 | Ceragem Co., Ltd. | 2021 | — |
| −1 | K220572 | Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 | Ceragem Co., Ltd. | 2022 | — |
| 0 (this device) | K240168 | N7-S | Nuga Medical Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 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 K241193 AGILIS - Multi-function Physical Therapy Table…score 9.1 · 2 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 |
|---|---|---|---|
| * | K220572 | Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702Summary page 6…ation of Predicate Device The identified predicate devices within this submission are shown as follow: Predicate device A 510(k) Number K220572 Applicant CERAGEM Co, Ltd. Regulation Name Multi-Function Physical Therapy Table T… | 2022 |
| * | K153054 | N5-1Summary page 6…Ceragem Automatic Thermal Massager Device Name CGM MB-1701 & CGM MB-1702 Predicate device B 510(k) Number K153054 Applicant NUGA MEDICAL Co., Ltd. Regulation Name Multi-Function Physical Therapy Table… | 2016 |
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.
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- None of the 11 ancestors has a 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. 2024, 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 N7-S is to provide patients with muscle relaxation therapy by delivering heatand 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.
The air massager module of N7-S is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas. The air massager module of N7-S stimulates kneading and stroking of tissues by using an inflatable garment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240168 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240168: N7-S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240168
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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