510(k) · Cleared
ClearedCUR Model 1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thimble Bioelectronics, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on May 20, 2016 as substantially equivalent to K140333 (Neurometrix, Inc., 2014) and 1 other predicate after a 130-day review. Its family tree reaches back 7 generations to 1988. 1 later device descends from it.
- Decided
- May 20, 2016
- Review
- 130 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K881114 (1988). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK881114 Empi Model 989, TensEmpi · 1988
- 6 generations backK970203 Epix VTEmpi · 1997
- 5 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 4 generations backK090922 Empi Active Transcutaneous Nerve StimulatorEmpi · 2009
- 3 generations backK121184 SensusNeurometrix, Inc. · 2012
- 2 generations backK130919 SensusNeurometrix, Inc. · 2013
- 1 generation backK140333 AscendNeurometrix, Inc. · 2014
- This deviceK160052 CUR Model 1Thimble Bioelectronics, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK233784 ENSO (Model 2)Hinge Health, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K233784ENSO (Model 2)Hinge Health, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −6 | K970203 | Epix VT | Empi | 1997 | — |
| −5 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −4 | K090922 | Empi Active Transcutaneous Nerve Stimulator | Empi | 2009 | — |
| −3 | K121184 | Sensus | Neurometrix, Inc. | 2012 | — |
| −2 | K130919 | Sensus | Neurometrix, Inc. | 2013 | — |
| −1 | K140333 | Ascend | Neurometrix, Inc. | 2014 | — |
| 0 (this device) | K160052 | CUR Model 1 | Thimble Bioelectronics, Inc. | 2016 | — |
| +1 | K233784 | ENSO (Model 2) | Hinge Health, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K140333 | Ascend Our reading of the summary gave K104333, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “NeuroMetrix ASCEND”. | 2014 |
| * | K151035 | PulseReliefSummary page 4…Neurology Predicate Devices The CUR device is substantially equivalent to the NeuroMetrix ASCEND (K104333) and the Philips Consumer Lifestyle PulseRelief (K151035) devices. Device Description CUR is a high-quality wearable medical device that provides professional-grade TENS… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233784 | ENSO (Model 2) | 2024 | 0 |
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 28 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K233784 (Hinge Health, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K140333.
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. 2016, 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?
A transcutaneous electrical nerve stimulation (TENS) Mode which is indicated for the 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. , and
A powered muscle stimulation (PMS) mode which is indicated to improve and facilitate muscle performance in healthy muscles.
The CUR Model 1 should be applied to normal, healthy, dry and clean skin of adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160052: CUR Model 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160052
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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