# K143198: Synapse Transcutaneous Electrical Stimulation Device

- Pathway: 510(k) (Traditional)
- Applicant: Synapse Electroceutical Limited
- Decided: May 27, 2015 after 202 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K881114 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130919: Sensus, Neurometrix, Inc. (2013) Summary page 4.

## Indications for use
The Synapse Transcutaneous Electrical Stimulation Device is intended for use for the symptomatic relief and management of chronic intractable pain. The Synapse Transcutaneous Electrical Stimulation Device may be used during sleep.

Source page: https://510kreport.com/device/K143198
Methodology: https://510kreport.com/methodology