# K904388: Pointer F-3 Tens

- Pathway: 510(k) (Traditional)
- Applicant: Oms Medical Supplies, Inc.
- Decided: Jun 4, 1991 after 252 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K051020: ES-160 (2006), 5 descendants of its own
- K062003: Neuro Wave 6 (2007), 3 descendants of its own
- K081255: Scrambler ST 5 Tens Device (2009), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K904388
Methodology: https://510kreport.com/methodology