510(k) · Cleared
ClearedPulseRelief
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Consumer Lifestyle · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Jul 21, 2015 as substantially equivalent to K130802 (Shenzhen Dongdixin Technology Co., Ltd., 2013) after a 95-day review. Its family tree reaches back 1 generation to 2013. 20 later devices descend from it.
- Decided
- Jul 21, 2015
- Review
- 95 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K130802 (2013). 20 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK130802 Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060)Shenzhen Dongdixin Technology Co., Ltd. · 2013
- This deviceK151035 PulseReliefPhilips Consumer Lifestyle · 2015
- Descendant · cites it directly · 5 of its ownK172079 AvailOmron Healthcare, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK163153 LiviaLifecare, Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK183110 LIVIALifecare, Ltd. · 2020
- Descendant · cites it directly · 3 of its ownK162479 Smart Pain Reliever, Model LT5019Shenzhen Dongdixin Technology Co., Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK173462 Wireless Pain Relieve Device Model: LT5018CShenzhen Dongdixin Technology Co., Ltd. · 2017
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K172079AvailOmron Healthcare, Inc. · 2017 · cites it directly5descendants
- K163153LiviaLifecare, Ltd. · 2017 · cites it directly4descendants
- K183110LIVIALifecare, Ltd. · 2020 · 2 generations on3descendants
- K162479Smart Pain Reliever, Model LT5019Shenzhen Dongdixin Technology Co., Ltd. · 2017 · cites it directly3descendants
- K173462Wireless Pain Relieve Device Model: LT5018CShenzhen Dongdixin Technology Co., Ltd. · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K130802 | Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060) | Shenzhen Dongdixin Technology Co., Ltd. | 2013 | — |
| 0 (this device) | K151035 | PulseRelief | Philips Consumer Lifestyle | 2015 | — |
| +1 | K172079 | Avail | Omron Healthcare, Inc. | 2017 | — |
| +1 | K163153 | Livia | Lifecare, Ltd. | 2017 | — |
| +2 | K183110 | LIVIA | Lifecare, Ltd. | 2020 | — |
| +1 | K162479 | Smart Pain Reliever, Model LT5019 | Shenzhen Dongdixin Technology Co., Ltd. | 2017 | — |
| +2 | K173462 | Wireless Pain Relieve Device Model: LT5018C | Shenzhen Dongdixin Technology Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | K130802 | Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060)Summary page 4…Device 510(k) # Product Code: Shenzhen OTC Electrical stimulator Models MT900I, LT3060 K 130802 NUH, NGX Dongdixin Technology Co., Ltd.… | 2013 |
What descends from it? (20)
See all 207 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?
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. 2015, 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 OTC TENS/EMS stimulator PulseRelief is designed 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.
It should be applied to normal, healthy, dry and clean skin of adult patients, and is to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151035 · printed Nov 5, 2026
Cite this page
510(k) Report. “K151035: PulseRelief.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K151035
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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