510(k) · Cleared
ClearedALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Mar 7, 2018 as substantially equivalent to K152852 (Bayer Healthcare, LLC, 2015) and 1 other predicate after a 261-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Mar 7, 2018
- Review
- 261 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K912178 (1991). 27 ancestors in all, the oldest K881114 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 6 generations backK972244 NT2000Bio-Medical Research, Ltd. · 1998
- 5 generations backK990787 TRIO 300Ito Co., Ltd. · 1999
- 4 generations backK013167 MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500Newcare Products, LLC · 2002
- 3 generations backK090042 Painmaster MCT PatchNewmark, Inc. · 2009
- 2 generations backK120500 The Pain Pilot (a.K.a Pain Pilot)Hollywog, LLC · 2012
- 1 generation backK152852 ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC · 2015
- This deviceK171802 ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)Bayer Healthcare, LLC · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −6 | K972244 | NT2000 | Bio-Medical Research, Ltd. | 1998 | — |
| −5 | K990787 | TRIO 300 | Ito Co., Ltd. | 1999 | — |
| −4 | K013167 | MODEL7500 Microcurrent Tens Device, MCT-F5, MCT-F50, MCT-F500 | Newcare Products, LLC | 2002 | — |
| −3 | K090042 | Painmaster MCT Patch | Newmark, Inc. | 2009 | — |
| −2 | K120500 | The Pain Pilot (a.K.a Pain Pilot) | Hollywog, LLC | 2012 | — |
| −1 | K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) | Bayer Healthcare, LLC | 2015 | — |
| 0 (this device) | K171802 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) | Bayer Healthcare, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 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 |
|---|---|---|---|
| * | K152852 | ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Summary page 4…er the counter use 2.1 Predicate Devices [807.92(a)(3)] ! ALEVE Direct Therapy TENS, first-generation (K152852) ! Chattem SmartRelief (K131159) 2.2 Device Description [807.92(a)(4)] The ALEVE® Direct The… | 2015 |
| * | K131159 | SmartreliefSummary page 4…counter use 2.1 Predicate Devices [807.92(a)(3)] ! ALEVE Direct Therapy TENS, first-generation (K152852) ! Chattem SmartRelief (K131159) 2.2 Device Description [807.92(a)(4)] The ALEVE® Direct Therapy® device is a battery powered transcutaneou… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- None of the 27 ancestors has a recall.
- 1 other device also cites its predicate K152852.
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. 2018, 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?
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. For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171802 · printed Nov 5, 2026
Cite this page
510(k) Report. “K171802: ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K171802
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