510(k) · Cleared
ClearedENSO (Model 2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hinge Health, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Feb 23, 2024 as substantially equivalent to K160052 (Thimble Bioelectronics, Inc., 2016) after an 88-day review. Its family tree reaches back 8 generations to 1988.
- Decided
- Feb 23, 2024
- Review
- 88 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K881114 (1988). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK881114 Empi Model 989, TensEmpi · 1988
- 7 generations backK970203 Epix VTEmpi · 1997
- 6 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 5 generations backK090922 Empi Active Transcutaneous Nerve StimulatorEmpi · 2009
- 4 generations backK121184 SensusNeurometrix, Inc. · 2012
- 3 generations backK130919 SensusNeurometrix, Inc. · 2013
- 2 generations backK140333 AscendNeurometrix, Inc. · 2014
- 1 generation backK160052 CUR Model 1Thimble Bioelectronics, Inc. · 2016
- This deviceK233784 ENSO (Model 2)Hinge Health, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −7 | K970203 | Epix VT | Empi | 1997 | — |
| −6 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −5 | K090922 | Empi Active Transcutaneous Nerve Stimulator | Empi | 2009 | — |
| −4 | K121184 | Sensus | Neurometrix, Inc. | 2012 | — |
| −3 | K130919 | Sensus | Neurometrix, Inc. | 2013 | — |
| −2 | K140333 | Ascend | Neurometrix, Inc. | 2014 | — |
| −1 | K160052 | CUR Model 1 | Thimble Bioelectronics, Inc. | 2016 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K160052 | CUR Model 1Summary page 5…and 21 CFR 890.5850 Class II Device Product Codes: NUH, NGX PREDICATE DEVICE INFORMATION Predicate Device: K160052 (CUR Model 1) Trade/Proprietary Name: CUR Model 1 Common Name: Transcutaneous Nerve Stimulator Classification Name… | 2016 |
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 36 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 12 ancestors has a recall.
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. 2024, 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 ENSO Model 2 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/K233784 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233784: ENSO (Model 2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233784
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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