510(k) · Cleared
ClearedOtc Ems Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Dongdixin Technology Co., Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Jun 16, 2014 after a 174-day review. The FDA summary names no predicate by number. 18 later devices descend from it.
- Decided
- Jun 16, 2014
- Review
- 174 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK133965 Otc Ems StimulatorShenzhen Dongdixin Technology Co., Ltd. · 2014
- Descendant · cites it directly · 17 of its ownK143207 Revitive IX (OTC)Actegy, Ltd. · 2015
- Descendant · 2 generations on · 11 of its ownK151834 BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · Recalled
- Descendant · 3 generations on · 5 of its ownK210174 BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2021
- Descendant · 3 generations on · 4 of its ownK203710 Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG · 2021
- Descendant · 4 generations on · 2 of its ownK240234 BTL-899MSBTL Industries, Inc. · 2024
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K143207Revitive IX (OTC)Actegy, Ltd. · 2015 · cites it directly17descendants
- K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · 2 generations on11descendants
- K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2021 · 3 generations on5descendants
- K203710Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG · 2021 · 3 generations on4descendants
- K240234BTL-899MSBTL Industries, Inc. · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K133965 | Otc Ems Stimulator | Shenzhen Dongdixin Technology Co., Ltd. | 2014 | — |
| +1 | K143207 | Revitive IX (OTC) | Actegy, Ltd. | 2015 | — |
| +2 | K151834 | BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2017 | 1 |
| +3 | K210174 | BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2021 | — |
| +3 | K203710 | Storz Medical MAGNETOLITH Muscle Stimulator | Storz Medical AG | 2021 | — |
| +4 | K240234 | BTL-899MS | BTL Industries, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143207 | Revitive IX (OTC) | 2015 | 17 |
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?
- Of its descendants, K143207 (Actegy, Ltd., 2015) has gone furthest, with 17 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. 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?
The OTC EMS stimulator MTIOO0I is intended to stimulate healthy muscles of the lower extremity in order to temporarily increase local blood circulation and 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/K133965 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133965: Otc Ems Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133965
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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