510(k) · Cleared
ClearedProspera Otc Tens Electronic Pulse Massager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prospera Corporation · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Mar 28, 2013 as substantially equivalent to K102598 (Hi-Dow International, Inc., 2011) and 2 other predicates after a 202-day review. Its family tree reaches back 4 generations to 1994. 55 later devices descend from it.
- Decided
- Mar 28, 2013
- Review
- 202 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K940301 (1994). 8 ancestors in all. 55 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 3 generations backK011880 Compex SportCompex S.A. · 2002
- 2 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 1 generation backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- This deviceK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- Descendant · cites it directly · 26 of its ownK133929 Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited · 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 · 2 generations on · 6 of its ownK190783 Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 2020
- Descendant · cites it directly · 6 of its ownK131921 Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd. · 2013
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K133929Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited · 2014 · cites it directly26descendants
- K143207Revitive IX (OTC)Actegy, Ltd. · 2015 · cites it directly17descendants
- K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · 2 generations on11descendants
- K190783Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 2020 · 2 generations on6descendants
- K131921Electronic Pulse StimulatorShenzhen Jingkehui Electronic Co.., Ltd. · 2013 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −3 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −2 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −1 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| 0 (this device) | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| +1 | K133929 | Health Expert Elctronic Stimulator | Shenzhen Osto Technology Company Limited | 2014 | — |
| +1 | K143207 | Revitive IX (OTC) | Actegy, Ltd. | 2015 | — |
| +2 | K151834 | BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2017 | 1 |
| +2 | K190783 | Health Expert Electronic Stimulator (model: AST-300L) | Shenzhen Osto Technology Company Limited | 2020 | — |
| +1 | K131921 | Electronic Pulse Stimulator | Shenzhen Jingkehui Electronic Co.., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 9 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 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 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? (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 |
|---|---|---|---|
| * | K102598 | HI-Dow-XPSummary page 2…Model Mnacurer I NUH Dtd JQ-5C Hi-Dow International, Inc. 21 CFR §882.5890 K102598 NGX 05/13/2011 21 CFR §882.5850 ____ ___ OT1C _… | 2011 |
| * | K060846 | Therapeutic Massage CompanionSummary page 2…_ _ _ _ _ _ _ _ NUH T1040 Endurance Therapeutics 21 CFR §882.5890 K060846 NGX 12/03/2007 21 GFR §882.5850 OTC __… | 2007 |
| * | K112392 | Hivox Biotek Inc.Summary page 2…OTC __ ____________ NUH PPO7 Hivox Biotek Inc. K112392 21 CFR §882.5890 03/19/2012 ______OTC I______________ The OTC pr… | 2012 |
What descends from it? (55)
See all 558 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K133929 (Shenzhen Osto Technology Company Limited, 2014) has gone furthest, with 26 descendants of its own.
- 8 other devices also cite its predicate K102598.
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. 2013, 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?
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K122744 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122744: Prospera Otc Tens Electronic Pulse Massager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122744
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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