# K172450: TENS device-HeadaTerm, eEspress

- Pathway: 510(k) (Traditional)
- Applicant: Wat Medical Technology (Ningbo) Co., Ltd.
- Decided: Sep 13, 2018 after 395 days
- Product code: PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine)
- Device class: 2
- Regulation: 21 CFR 882.5891
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN120019 (2014). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN120019: Cefaly, Stx-Med Sprl (2014). 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.
- K160237: Cefaly, Cefaly Technology (2016) Summary page 5.

## Most influential descendants
- K230782: TENS device-HeadaTerm 2 (Model: YF-HT2) (2024), 0 descendants of its own

## Indications for use
The TENS device-HeadaTerm is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

Source page: https://510kreport.com/device/K172450
Methodology: https://510kreport.com/methodology