510(k) · Cleared
ClearedLivia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifecare, Ltd. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Jun 28, 2017 as substantially equivalent to K151035 (Philips Consumer Lifestyle, 2015) after a 230-day review. Its family tree reaches back 2 generations to 2013. 4 later devices descend from it.
- Decided
- Jun 28, 2017
- Review
- 230 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K130802 (2013). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK130802 Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060)Shenzhen Dongdixin Technology Co., Ltd. · 2013
- 1 generation backK151035 PulseReliefPhilips Consumer Lifestyle · 2015
- This deviceK163153 LiviaLifecare, Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK183110 LIVIALifecare, Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK233054 Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator…Well-Life Healthcare Limited · 2024
- Descendant · 2 generations on · 0 of its ownK230926 Ova+ (K-OVAP-USA)Tenscare, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK220997 Wireless TENS/EMS, Bruno, AelaZmi Elecronics, Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K183110LIVIALifecare, Ltd. · 2020 · cites it directly3descendants
- K233054Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual…Well-Life Healthcare Limited · 2024 · 2 generations on0descendants
- K230926Ova+ (K-OVAP-USA)Tenscare, Ltd. · 2023 · 2 generations on0descendants
- K220997Wireless TENS/EMS, Bruno, AelaZmi Elecronics, Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K130802 | Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060) | Shenzhen Dongdixin Technology Co., Ltd. | 2013 | — |
| −1 | K151035 | PulseRelief | Philips Consumer Lifestyle | 2015 | — |
| 0 (this device) | K163153 | Livia | Lifecare, Ltd. | 2017 | — |
| +1 | K183110 | LIVIA | Lifecare, Ltd. | 2020 | — |
| +2 | K233054 | Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH… | Well-Life Healthcare Limited | 2024 | — |
| +2 | K230926 | Ova+ (K-OVAP-USA) | Tenscare, Ltd. | 2023 | — |
| +2 | K220997 | Wireless TENS/EMS, Bruno, Aela | Zmi Elecronics, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K151035 | PulseReliefSummary page 4…21 CFR Part 882.5890 Product Code: NUH 4. Predicate Device Information: Primary Predicate: Philips Consumer Lifestyle PulseRelief (K151035) Reference Predicate: NeuroMetrix ASCEND (K10433) 5. Device Description: The LIVIA is a TENS dev… | 2015 |
| † | K104333 | NeuroMetrix ASCEND |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183110 | LIVIA | 2020 | 3 |
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 4 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K183110 (Lifecare, Ltd., 2020) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K151035.
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. 2017, 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 Livia is designed for symptomatic relief and management of chronic intractable pain, and 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/K163153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163153: Livia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163153
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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