510(k) · Cleared
ClearedEMS Belt (Model MC0485)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dongguan Yingfeng Metal & Plastic Products Co., Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Sep 18, 2019 as substantially equivalent to K171803 (Hivox Biotek, Inc., 2017) and 2 other predicates after a 315-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Sep 18, 2019
- Review
- 315 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K940301 (1994). 30 ancestors in all, the oldest K872976 (1987). No later device cites it as a predicate yet.
- Root · 7 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 6 generations backK011880 Compex SportCompex S.A. · 2002
- 5 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 4 generations backK110068 Model PM3030Omron Healthcare, Inc. · 2011
- 3 generations backK132993 Counter Otc Tens DeviceCounter Scientific Development (Gz), Ltd. · 2014
- 2 generations backK150386 Tyece OTC TENS DeviceTyece, Ltd. · 2015
- 1 generation backK171803 HIVOX OTC Electrical StimulatorHivox Biotek, Inc. · 2017
- This deviceK183103 EMS Belt (Model MC0485)Dongguan Yingfeng Metal & Plastic Products Co., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −6 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −5 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −4 | K110068 | Model PM3030 | Omron Healthcare, Inc. | 2011 | — |
| −3 | K132993 | Counter Otc Tens Device | Counter Scientific Development (Gz), Ltd. | 2014 | — |
| −2 | K150386 | Tyece OTC TENS Device | Tyece, Ltd. | 2015 | — |
| −1 | K171803 | HIVOX OTC Electrical Stimulator | Hivox Biotek, Inc. | 2017 | — |
| 0 (this device) | K183103 | EMS Belt (Model MC0485) | Dongguan Yingfeng Metal & Plastic Products Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K171803 | HIVOX OTC Electrical StimulatorSummary page 4…ate Device 510(k) Number Approval Date (Primary) HIVOX OTC Hivox Biotek Inc. K171803 Nov. 29, 2017 Electrical Stimulator/SEM44 Shenzhen OSTO Health Expert… | 2017 |
| * | K133929 | Health Expert Elctronic StimulatorSummary page 4…2017 Electrical Stimulator/SEM44 Shenzhen OSTO Health Expert Electronic Technology Company Stimulator/AST-300C and K133929 Nov. 12, 2014 Limited AST-300D Actegy, Ltd Revitive IX (OTC)/RIX… | 2014 |
| * | K143207 | Revitive IX (OTC)Summary page 4…any Stimulator/AST-300C and K133929 Nov. 12, 2014 Limited AST-300D Actegy, Ltd Revitive IX (OTC)/RIX K143207 Mar. 23, 2015 Reference device(s): Manufacturer Reference Device 510(k) Number… | 2015 |
| † | K143430 | SmartTENS | 2015 |
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 25 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- None of the 30 ancestors has a recall.
- 10 other devices also cite its predicate K171803.
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. 2019, 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?
To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183103 · printed Nov 3, 2026
Cite this page
510(k) Report. “K183103: EMS Belt (Model MC0485).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K183103
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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