# K181645: StimaWELL 120MTRS

- Pathway: 510(k) (Traditional)
- Applicant: Pierenkemper GmbH
- Decided: Aug 13, 2020 after 783 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 K931781 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131917: Neurodyn Compact, Neurodyn II, Ibramed Equipamentos Medicos (2014) Summary page 5.

## Indications for use
TENS mode: - Symptomatic relief of chronic (long term) intractable pain - Symptomatic relief of post-traumatic acute pain and post surgical pain Russian mode: - Temporary relaxation of muscle spasms in back area - Prevention or retardation of disuse atrophy of the lumbar paraspinal muscles

Source page: https://510kreport.com/device/K181645
Methodology: https://510kreport.com/methodology