510(k) · Cleared
ClearedHealth Expert Elctronic Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Osto Technology Company Limited · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Nov 12, 2014 as substantially equivalent to K121719 (Hong Qiangxing (Shenzhen) Electronics Limited, 2013) and 1 other predicate after a 324-day review. Its family tree reaches back 5 generations to 1994. 26 later devices descend from it.
- Decided
- Nov 12, 2014
- Review
- 324 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K940301 (1994). 10 ancestors in all. 26 later devices descend from it, 15 citing it directly.
- Root · 5 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 4 generations backK011880 Compex SportCompex S.A. · 2002
- 3 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 2 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 1 generation backK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- This deviceK133929 Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited · 2014
- Descendant · cites it directly · 6 of its ownK190783 Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 2020
- Descendant · cites it directly · 3 of its ownK172897 Neck Care Therapy, Model: SYK 509BShenzhen Osto Technology Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK191982 Low-Frequency Multi-function Physiotherapy Instrument (Model…Shenzhen Kentro Medical Electronics Co., Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK163611 Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK211942 Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623…Shenzhen Osto Technology Company Limited · 2021
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K190783Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 2020 · cites it directly6descendants
- K172897Neck Care Therapy, Model: SYK 509BShenzhen Osto Technology Co., Ltd. · 2018 · cites it directly3descendants
- K191982Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220…Shenzhen Kentro Medical Electronics Co., Ltd. · 2020 · cites it directly2descendants
- K163611Pain Therapy DeviceGuangzhou Xinbo Electronic Co., Ltd. · 2017 · cites it directly2descendants
- K211942Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B)Shenzhen Osto Technology Company Limited · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −4 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −3 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −2 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −1 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| 0 (this device) | K133929 | Health Expert Elctronic Stimulator | Shenzhen Osto Technology Company Limited | 2014 | — |
| +1 | K190783 | Health Expert Electronic Stimulator (model: AST-300L) | Shenzhen Osto Technology Company Limited | 2020 | — |
| +1 | K172897 | Neck Care Therapy, Model: SYK 509B | Shenzhen Osto Technology Co., Ltd. | 2018 | — |
| +1 | K191982 | Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230… | Shenzhen Kentro Medical Electronics Co., Ltd. | 2020 | — |
| +1 | K163611 | Pain Therapy Device | Guangzhou Xinbo Electronic Co., Ltd. | 2017 | — |
| +2 | K211942 | Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) | Shenzhen Osto Technology Company Limited | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 6 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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 NUH? 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 NUH device
- #1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 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 |
|---|---|---|---|
| * | K121719 | SM Tens & PMSSummary page 4…Massager and Model Model: SM9128 Model: PL029 510(k) Number K121719 K122744 Product Code NUH, NGX NUH, NGX Regulation… | 2013 |
| * | K122744 | Prospera Otc Tens Electronic Pulse MassagerSummary page 4…del Model: SM9128 Model: PL029 510(k) Number K121719 K122744 Product Code NUH, NGX NUH, NGX Regulation 882.5890, 890.5… | 2013 |
What descends from it? (26)
See all 2615 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190783 | Health Expert Electronic Stimulator (model: AST-300L) | 2020 | 6 |
| K172897 | Neck Care Therapy, Model: SYK 509B | 2018 | 3 |
| K191982 | Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220… | 2020 | 2 |
| K163611 | Pain Therapy Device | 2017 | 2 |
| K190673 | Health Expert Electronic Stimulator | 2019 | 1 |
| K241678 | TENS & EMS Stimulator (MHD-1083) | 2024 | 0 |
| K240292 | Transcutaneous Electrical Nerve Stimulator (9029SCM) | 2024 | 0 |
| K232439 | Electrical Stimulator System | 2024 | 0 |
| K183674 | Electronic Pulse Stimulator | 2019 | 0 |
| K182136 | Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) | 2019 | 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 20 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K190783 (Shenzhen Osto Technology Company Limited, 2020) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K121719.
How does its category compare?
All NUH devicesNUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NUH
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUH
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUH
No recall names NUH since 2007.
Adverse event reports per year · NUH
7in 2025
MAUDE reports naming product code NUH, 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 | 4 | 161 | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 148 | 0 | 0 |
| 2011 | 6 | 231 | 0 | 0 |
| 2012 | 6 | 170 | 0 | 0 |
| 2013 | 10 | 189 | 0 | 1 |
| 2014 | 16 | 212 | 0 | 9 |
| 2015 | 14 | 198 | 0 | 11 |
| 2016 | 13 | 145 | 0 | 13 |
| 2017 | 17 | 155 | 0 | 21 |
| 2018 | 16 | 121 | 0 | 18 |
| 2019 | 19 | 213 | 0 | 5 |
| 2020 | 14 | 147 | 0 | 8 |
| 2021 | 14 | 198 | 0 | 7 |
| 2022 | 20 | 103 | 0 | 2 |
| 2023 | 15 | 127 | 0 | 4 |
| 2024 | 20 | 90 | 0 | 7 |
| 2025 | 15 | 119 | 0 | 7 |
| 2026 | 5 | 137 | 0 | — |
What is it indicated for?
PMS (Mode 1~8)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 9~25)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133929: Health Expert Elctronic Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133929
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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