510(k) · Cleared
ClearedHivox Spopad Ems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hivox Biotek, Inc. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Jan 16, 2015 as substantially equivalent to K092476 (Sport-Elec, 2010) after a 184-day review. Its family tree reaches back 6 generations to 2001. 2 later devices descend from it.
- Decided
- Jan 16, 2015
- Review
- 184 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010335 (2001). 10 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 5 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 4 generations backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- 3 generations backK072553 System-Arms, Model 390,E60Bio-Medical Research, Ltd. · 2007
- 2 generations backK091865 Sport-Elec Body Control SystemSport-Elec · 2009
- 1 generation backK092476 Sport-Elec Body Control System, Model 4MSport-Elec · 2010
- This deviceK141921 Hivox Spopad EmsHivox Biotek, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK192264 HIVOX Spopad EMS SP-911, SP-921Hivox Biotek, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK241119 Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology 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 |
|---|---|---|---|---|---|
| −6 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −5 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −4 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| −3 | K072553 | System-Arms, Model 390,E60 | Bio-Medical Research, Ltd. | 2007 | — |
| −2 | K091865 | Sport-Elec Body Control System | Sport-Elec | 2009 | — |
| −1 | K092476 | Sport-Elec Body Control System, Model 4M | Sport-Elec | 2010 | — |
| 0 (this device) | K141921 | Hivox Spopad Ems | Hivox Biotek, Inc. | 2015 | — |
| +1 | K192264 | HIVOX Spopad EMS SP-911, SP-921 | Hivox Biotek, Inc. | 2019 | — |
| +2 | K241119 | Transcutaneous Electrical Nerve Stimulator (K6106) | Shenzhen Yicai Health Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 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? (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 |
|---|---|---|---|
| * | K092476 | Sport-Elec Body Control System, Model 4MSummary page 6…Spopad EMS, SP series Model number 4M SP-910 SP-920 SP-620 510(k) number K092476 TBA TBA TBA Product code NGX… | 2010 |
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 |
|---|---|---|---|
| K192264 | HIVOX Spopad EMS SP-911, SP-921 | 2019 | 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 14 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K192264 (Hivox Biotek, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K092476.
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. 2015, 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?
These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141921: Hivox Spopad Ems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141921
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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