510(k) · Cleared
ClearedFDES106 Mini Tens&Ems Device,FDES106 Multi-Function Mini Tens&Ems Device,FDES105 Pain Relief Plaster,FDES107 Abdominal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Famidoc Technology Co., Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Feb 7, 2014 as substantially equivalent to K060846 (Endurance Therapeutics, 2007) and 1 other predicate after a 326-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Feb 7, 2014
- Review
- 326 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940301 (1994). 7 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 2 generations backK011880 Compex SportCompex S.A. · 2002
- 1 generation backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- This deviceK130723 FDES106 Mini Tens&Ems Device,FDES106 Multi-Function Mini Tens&Ems…Famidoc Technology Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK163393 Hi-Dow Wireless TENS/EMS System (Model HD-5N)Hi-Dow International, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK241785 StarFormer (M008-3T)Fotona D.O.O. · 2025
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 |
|---|---|---|---|---|---|
| −3 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −2 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −1 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| 0 (this device) | K130723 | FDES106 Mini Tens&Ems Device,FDES106 Multi-Function Mini Tens&Ems… | Famidoc Technology Co., Ltd. | 2014 | — |
| +1 | K163393 | Hi-Dow Wireless TENS/EMS System (Model HD-5N) | Hi-Dow International, Inc. | 2017 | — |
| +2 | K241785 | StarFormer (M008-3T) | Fotona D.O.O. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2025 | 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 NGX? 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 NGX device
- #1 K250146 SofWave Systemscore 15.5 · 12 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 |
|---|---|---|---|
| * | K060846 | Therapeutic Massage CompanionSummary page 2…TM Abdominal Training system type 515 510 (K) Number K060846 K030708 4. Description of Device[21 CIFR 807.92(a)(4)] The FDES1O6(ED406) Series Stimulator, whi… | 2007 |
| * | K030708 | Slendertone Flex Abdominal Training System, Type 515Summary page 2…raining system type 515 510 (K) Number K060846 K030708 4. Description of Device[21 CIFR 807.92(a)(4)] The FDES1O6(ED406) Series Stimulator, which includes models FDES1O6(ED… | 2003 |
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 |
|---|---|---|---|
| K163393 | Hi-Dow Wireless TENS/EMS System (Model HD-5N) | 2017 | 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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K163393 (Hi-Dow International, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K060846.
How does its category compare?
All NGX devicesNGX Stimulator, Muscle, Powered, For Muscle Conditioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NGX
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGX
93in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGX
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGX
15in 2025
MAUDE reports naming product code NGX, 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 | 7 | 135 | 0 | 0 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 4 | 132 | 0 | 0 |
| 2010 | 6 | 180 | 0 | 0 |
| 2011 | 5 | 291 | 0 | 1 |
| 2012 | 3 | 362 | 0 | 0 |
| 2013 | 6 | 269 | 2 | 1 |
| 2014 | 6 | 298 | 0 | 0 |
| 2015 | 9 | 184 | 0 | 7 |
| 2016 | 4 | 240 | 0 | 21 |
| 2017 | 10 | 108 | 0 | 2 |
| 2018 | 6 | 104 | 0 | 6 |
| 2019 | 14 | 167 | 0 | 4 |
| 2020 | 11 | 207 | 0 | 7 |
| 2021 | 12 | 256 | 0 | 5 |
| 2022 | 6 | 307 | 0 | 7 |
| 2023 | 12 | 96 | 0 | 8 |
| 2024 | 12 | 207 | 0 | 11 |
| 2025 | 15 | 93 | 0 | 15 |
| 2026 | 4 | 118 | 0 | — |
What is it indicated for?
FDES 106 (ED406) Mini TENS &EMS Device For program NI, B and H of TENS mode To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities. For program El and E2 of EMS mode Used to stimulate healthy muscles in order to improve and facilitate muscle performance. FDES1O6A (ED4O6AJ Multi-function Mini TENS &EMS Device For pro gram NI1, B and H of TENS mode To be used for…
Read the full statement (190 words)
FDES 106 (ED406) Mini TENS &EMS Device
For program NI, B and H of TENS mode
To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities.
For program El and E2 of EMS mode
Used to stimulate healthy muscles in order to improve and facilitate muscle performance.
FDES1O6A (ED4O6AJ Multi-function Mini TENS &EMS Device
For pro gram NI1, B and H of TENS mode
To be used for temporary relief of pain associated with sore and aching muscles in the lower back, abdomen, thigh, and arm due to strain from exercise or normal household work activities.
For pro gram El and E2 of EMS mode
Used to stimulate healthy muscles in the lower back, abdomen, thigh, and arm in order to improve and facilitate muscle performance.
FDES1O5 (ED405) Pain Relief Plaster
To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities.
FDES 107 (ED407) Abdominal Fitness Belt
Used to stimulate healthy muscles in order to improve and facilitate muscle performance for abdominal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130723: FDES106 Mini Tens&Ems Device,FDES106 Multi-Function Mini Tens&Ems Device,FDES105 Pain Relief Plaster,FDES107 Abdominal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130723
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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