# K131513: Scenar (Scelap, Enisar, Ipens) Cutaneous Electrode Family

- Pathway: 510(k) (Traditional)
- Applicant: Ritm Okb Zao
- Decided: Jul 11, 2014 after 409 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: 4 generations back to K951951 (1996). 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)
- K092117: Scenar, Model 10, Ritm Okb Zao (2010) Summary page 1.
- K042912: INTERX5000, Neuro Resource Group, Inc. (2005) Summary page 1.

## Indications for use
The SCENAR Cutaneous Electrode Family with SCENAR TENS devices is indicated for relief and management of chronic and acute pain, as adjunctive treatment in the management of post-surgical and post-traumatic pain.

Source page: https://510kreport.com/device/K131513
Methodology: https://510kreport.com/methodology