510(k) · Cleared
ClearedHivox Biotek Inc.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hivox Biotek, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Mar 19, 2012 as substantially equivalent to K060846 (Endurance Therapeutics, 2007) and 1 other predicate after a 214-day review. Its family tree reaches back 3 generations to 1994. 58 later devices descend from it.
- Decided
- Mar 19, 2012
- Review
- 214 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940301 (1994). 6 ancestors in all. 58 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 2 generations backK011880 Compex SportCompex S.A. · 2002
- 1 generation backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- This deviceK112392 Hivox Biotek Inc.Hivox Biotek, Inc. · 2012
- Descendant · cites it directly · 55 of its ownK122744 Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013
- Descendant · 2 generations on · 26 of its ownK133929 Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited · 2014
- Descendant · 2 generations on · 17 of its ownK143207 Revitive IX (OTC)Actegy, Ltd. · 2015
- Descendant · 3 generations on · 11 of its ownK151834 BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · Recalled
- Descendant · 3 generations on · 6 of its ownK190783 Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 2020
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K122744Prospera Otc Tens Electronic Pulse MassagerProspera Corporation · 2013 · cites it directly55descendants
- K133929Health Expert Elctronic StimulatorShenzhen Osto Technology Company Limited · 2014 · 2 generations on26descendants
- K143207Revitive IX (OTC)Actegy, Ltd. · 2015 · 2 generations on17descendants
- K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · 3 generations on11descendants
- K190783Health Expert Electronic Stimulator (model: AST-300L)Shenzhen Osto Technology Company Limited · 2020 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −2 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −1 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| 0 (this device) | K112392 | Hivox Biotek Inc. | Hivox Biotek, Inc. | 2012 | — |
| +1 | K122744 | Prospera Otc Tens Electronic Pulse Massager | Prospera Corporation | 2013 | — |
| +2 | K133929 | Health Expert Elctronic Stimulator | Shenzhen Osto Technology Company Limited | 2014 | — |
| +2 | K143207 | Revitive IX (OTC) | Actegy, Ltd. | 2015 | — |
| +3 | K151834 | BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2017 | 1 |
| +3 | K190783 | Health Expert Electronic Stimulator (model: AST-300L) | Shenzhen Osto Technology Company Limited | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 4 | 0 |
| 2014 | 3 | 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 | 6 | 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? (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 |
|---|---|---|---|
| * | K060846 | Therapeutic Massage CompanionSummary page 1…90 NUMBER: SECONDARY GZJ, Class 11, 882.5890 PRODUCT CODE: PREDICATED Therapeutic Massage Companion, Endurance Therapeutics DEVICE: 1) K060846, OTC TENS for Lower Back, Arm and Leg Pain Relief, T1040 WELL-LIFE Healthcare Limite… | 2007 |
| * | K040512 | Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and WL-2401Summary page 1…1) K060846, OTC TENS for Lower Back, Arm and Leg Pain Relief, T1040 WELL-LIFE Healthcare Limited 2) K0405 12, Limited Function OTC TENS, for Lower Back Pain Relief, WL-2402, WL-2403… | 2004 |
What descends from it? (58)
See all 582 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 18 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K122744 (Prospera Corporation, 2013) has gone furthest, with 55 descendants of its own.
- 10 other devices also cite its predicate K060846.
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. 2012, 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?
The Pennypad 904 and Pennypad 909 are indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
The Pennypad 907 is indicated for Arm & Leg Pain Relief is intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112392: Hivox Biotek Inc..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112392
Report an extraction error
Are you the manufacturer?
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