# K201458: Scrambler Therapy Technology (Model ST-5A)

- Pathway: 510(k) (Abbreviated)
- Applicant: Delta International Services & Logistics S.R.L
- Decided: Dec 23, 2020 after 205 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: 5 generations back to K904388 (1991). 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)
- K142666: Scrambler Therapy MC-5 A Device, Delta International Services & Logistics S.R.L (2015) Summary page 4.

## Indications for use
General Indications for Use : • Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain. • Symptomatic relief of acute pain. • Symptomatic relief of post-operative pain.

Source page: https://510kreport.com/device/K201458
Methodology: https://510kreport.com/methodology