# K081255: Scrambler ST 5 Tens Device

- Pathway: 510(k) (Traditional)
- Applicant: Competitive Technologies,Inc.
- Decided: Feb 20, 2009 after 294 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: 3 generations back to K904388 (1991). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051020: ES-160, Lhasa Oms, Inc. (2006) Summary page 1.
- K062003: Neuro Wave 6, Lhasa Oms, Inc. (2007) Summary page 1.

## Most influential descendants
- K142666: Scrambler Therapy MC-5 A Device (2015), 1 descendant of its own
- K201458: Scrambler Therapy Technology (Model ST-5A) (2020), 0 descendants of its own

## Indications for use
The Scrambler Therapy MC-5A TENS Device is indicated for: 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/K081255
Methodology: https://510kreport.com/methodology