510(k) · Cleared
ClearedMigraine Tens Digital Pain Reliever
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Dongdixin Technology Co., Ltd. · PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Cleared on Jun 17, 2021 as substantially equivalent to K201895 (Cefaly Technology, 2020) after a 129-day review. Its family tree reaches back 5 generations to 2014.
- Decided
- Jun 17, 2021
- Review
- 129 days
- Class
- Class II
- Product code
- PCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN120019 (2014). No later device cites it as a predicate yet.
- Root · 5 generations backDEN120019 CefalyStx-Med Sprl · 2014
- 4 generations backK160237 CefalyCefaly Technology · 2016
- 3 generations backK171446 Cefaly AcuteCefaly Technology · 2017
- 2 generations backK173006 Cefaly DualCefaly Technology · 2017
- 1 generation backK201895 Cefaly DualCefaly Technology · 2020
- This deviceK210364 Migraine Tens Digital Pain RelieverShenzhen Dongdixin Technology Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN120019 | Cefaly | Stx-Med Sprl | 2014 | — |
| −4 | K160237 | Cefaly | Cefaly Technology | 2016 | — |
| −3 | K171446 | Cefaly Acute | Cefaly Technology | 2017 | — |
| −2 | K173006 | Cefaly Dual | Cefaly Technology | 2017 | — |
| −1 | K201895 | Cefaly Dual | Cefaly Technology | 2020 | — |
| 0 (this device) | K210364 | Migraine Tens Digital Pain Reliever | Shenzhen Dongdixin Technology Co., Ltd. | 2021 | — |
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? (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 |
|---|---|---|---|
| * | K201895 | Cefaly DualSummary page 5…Device Class: II 2. Predicate Device: Legally Marketed Device: Cefaly® Dual 510(k) Number: K201895 Manufacturer: CEFALY Technology 3. Device Description: The Migraine TENS Digital Pain Rel… | 2020 |
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 7 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 5 ancestors has a recall.
- 4 other devices also cite its predicate K201895.
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. 2021, 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?
Migraine TENS Digital Pain Reliever LT1103
- The acute treatment of migraine with or without aura in patients 18 years of age or older.
- The prophylactic treatment of episodic migraine in patients 18 years of age or older.
Migraine TENS Digital Pain Reliever LT1103-P
- 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/K210364 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210364: Migraine Tens Digital Pain Reliever.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210364
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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