# K110390: Etg 255 Combo Stimualtor, Ten 260 Stimualtor

- Pathway: 510(k) (Traditional)
- Applicant: Handelshaus Dittman GmbH
- Decided: Jul 29, 2011 after 168 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: 2 generations back to K040512 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060222: Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PP, Gemore Technology Co, Ltd. (2006) Summary page 2.

## Indications for use
Care back pain relief stimulator is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain form exercise or normal household and working activities.

Source page: https://510kreport.com/device/K110390
Methodology: https://510kreport.com/methodology