# K210364: Migraine Tens Digital  Pain  Reliever

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dongdixin Technology Co., Ltd.
- Decided: Jun 17, 2021 after 129 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: 5 generations back to DEN120019 (2014). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201895: Cefaly Dual, Cefaly Technology (2020) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K210364
Methodology: https://510kreport.com/methodology