# K251026: Regenesis EMS Chair

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Medical Solutions
- Decided: Aug 29, 2025 after 149 days
- Product code: KPI (Stimulator, Electrical, Non-Implantable, For Incontinence)
- Device class: 2
- Regulation: 21 CFR 876.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K930530 (1995). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181497: HPM-6000UF, BTL Industries, Inc. (2018) Summary page 5.

## Indications for use
The ReGenesis EMS Chair is intended to provide non-invasive electromagnetic stimulation to a weak pelvic floor muscle for the purpose of rehabilitation. The procedure is intended to strengthen the pelvic floor muscle and restore the neuromuscular control for the treatment of urinary incontinence in both male and female patients.

Source page: https://510kreport.com/device/K251026
Methodology: https://510kreport.com/methodology