# K213133: Keffort (MC-100, MC-100A)

- Pathway: 510(k) (Traditional)
- Applicant: Oriental Inspiration Limited
- Decided: Apr 13, 2022 after 198 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence for female patients and to maintain urinary continence for female patients.

Source page: https://510kreport.com/device/K213133
Methodology: https://510kreport.com/methodology