510(k) · Cleared
ClearedHIVOX Spopad EMS SP-911, SP-921
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 Nov 8, 2019 as substantially equivalent to K141921 (Hivox Biotek, Inc., 2015) after a 79-day review. Its family tree reaches back 7 generations to 2001. 1 later device descends from it.
- Decided
- Nov 8, 2019
- Review
- 79 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K010335 (2001). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 6 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 5 generations backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- 4 generations backK072553 System-Arms, Model 390,E60Bio-Medical Research, Ltd. · 2007
- 3 generations backK091865 Sport-Elec Body Control SystemSport-Elec · 2009
- 2 generations backK092476 Sport-Elec Body Control System, Model 4MSport-Elec · 2010
- 1 generation backK141921 Hivox Spopad EmsHivox Biotek, Inc. · 2015
- This deviceK192264 HIVOX Spopad EMS SP-911, SP-921Hivox Biotek, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK241119 Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K241119Transcutaneous Electrical Nerve Stimulator (K6106)Shenzhen Yicai Health Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −6 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −5 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| −4 | K072553 | System-Arms, Model 390,E60 | Bio-Medical Research, Ltd. | 2007 | — |
| −3 | K091865 | Sport-Elec Body Control System | Sport-Elec | 2009 | — |
| −2 | K092476 | Sport-Elec Body Control System, Model 4M | Sport-Elec | 2010 | — |
| −1 | K141921 | Hivox Spopad Ems | Hivox Biotek, Inc. | 2015 | — |
| 0 (this device) | K192264 | HIVOX Spopad EMS SP-911, SP-921 | Hivox Biotek, Inc. | 2019 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K141921 | Hivox Spopad EmsSummary page 5…ntification of the Predicate Device Proprietary/Trade name: HIVOX Spopad EMS Models: SP-910, SP-920 510(k) number: K141921 Classification product code: NGX Regulation number: 890.5850 Regulation description: Power muscle st… | 2015 |
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 |
|---|---|---|---|
| K241119 | Transcutaneous Electrical Nerve Stimulator (K6106) | 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 18 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K241119 (Shenzhen Yicai Health Technology Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
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?
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/K192264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192264: HIVOX Spopad EMS SP-911, SP-921.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192264
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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