510(k) · Cleared
ClearedTENS device-HeadaTerm, eEspress
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wat Medical Technology (Ningbo) Co., Ltd. · PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Cleared on Sep 13, 2018 as substantially equivalent to DEN120019 (Stx-Med Sprl, 2014) and 1 other predicate after a 395-day review. Its family tree reaches back 2 generations to 2014. 1 later device descends from it.
- Decided
- Sep 13, 2018
- Review
- 395 days
- Class
- Class II
- Product code
- PCC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN120019 (2014). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN120019 CefalyStx-Med Sprl · 2014
- 1 generation backK160237 CefalyCefaly Technology · 2016
- This deviceK172450 TENS device-HeadaTerm, eEspressWat Medical Technology (Ningbo) Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK230782 TENS device-HeadaTerm 2 (Model: YF-HT2)Wat Medical Technology, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K230782TENS device-HeadaTerm 2 (Model: YF-HT2)Wat Medical Technology, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN120019 | Cefaly | Stx-Med Sprl | 2014 | — |
| −1 | K160237 | Cefaly | Cefaly Technology | 2016 | — |
| 0 (this device) | K172450 | TENS device-HeadaTerm, eEspress | Wat Medical Technology (Ningbo) Co., Ltd. | 2018 | — |
| +1 | K230782 | TENS device-HeadaTerm 2 (Model: YF-HT2) | Wat Medical Technology, Inc. | 2024 | — |
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 PCC? 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 PCC device
- #1 K201895 Cefaly Dualscore 16.0 · 4 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 |
|---|---|---|---|
| * | DEN120019 | Cefaly Our reading of the summary gave K122566, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120019, Cefaly (Stx-Med Sprl), granted Mar 11, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2014 |
| * | K160237 | CefalySummary page 5…headache Regulation Number: 21 CFR 882.5891 Classification: Class II FDA 510 (k) #: K122566 (Primary), K160237 5. Description of the Device [21 CFR 807.92(a)(4)] TENS device-HeadaTerm offers a drug-free scheme, which introduces electric… | 2016 |
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 |
|---|---|---|---|
| K230782 | TENS device-HeadaTerm 2 (Model: YF-HT2) | 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 4 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K230782 (Wat Medical Technology, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate DEN120019.
How does its category compare?
All PCC devicesPCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PCC
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PCC
211in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PCC
No recall names PCC since 2007.
Adverse event reports per year · PCC
2in 2025
MAUDE reports naming product code PCC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 4 | 88 | 0 | 7 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 5 | 211 | 0 | 6 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The TENS device-HeadaTerm is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K172450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172450: TENS device-HeadaTerm, eEspress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172450
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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