510(k) · Cleared
ClearedPain Buddy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Life Systems, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Jul 29, 2011 after a 373-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jul 29, 2011
- Review
- 373 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK102051 Pain BuddyBiomedical Life Systems, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK152374 LL Tens 160A, LL Tens 160BFuji Dynamics, Ltd. · 2016
- Descendant · 2 generations on · 2 of its ownK210223 Transcutaneous Electrical Nerve StimulatorTop-Rank Health Care Co., Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK231425 Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)Wuxi Jiajian Medical Instrument Co., Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK252688 Transcutaneous Electrical Nerve Stimulator (RJTENS-2)Bozhou Rongjian Medical Appliance Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK160255 HBOTC Muscle and Nerve StimulatorHb Medical, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K152374LL Tens 160A, LL Tens 160BFuji Dynamics, Ltd. · 2016 · cites it directly3descendants
- K210223Transcutaneous Electrical Nerve StimulatorTop-Rank Health Care Co., Ltd. · 2021 · 2 generations on2descendants
- K231425Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)Wuxi Jiajian Medical Instrument Co., Ltd. · 2024 · 3 generations on1descendant
- K252688Transcutaneous Electrical Nerve Stimulator (RJTENS-2)Bozhou Rongjian Medical Appliance Co., Ltd. · 2025 · 4 generations on0descendants
- K160255HBOTC Muscle and Nerve StimulatorHb Medical, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102051 | Pain Buddy | Biomedical Life Systems, Inc. | 2011 | — |
| +1 | K152374 | LL Tens 160A, LL Tens 160B | Fuji Dynamics, Ltd. | 2016 | — |
| +2 | K210223 | Transcutaneous Electrical Nerve Stimulator | Top-Rank Health Care Co., Ltd. | 2021 | — |
| +3 | K231425 | Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2024 | — |
| +4 | K252688 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2025 | — |
| +1 | K160255 | HBOTC Muscle and Nerve Stimulator | Hb Medical, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
2 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?
- Of its descendants, K152374 (Fuji Dynamics, Ltd., 2016) has gone furthest, with 3 descendants of its own.
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. 2011, 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?
T.E.N.S. stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K102051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102051: Pain Buddy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102051
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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