# K220161: Biofeedback Nerve and Muscle Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Konmed Technology Co., Ltd.
- Decided: Jul 20, 2022 after 181 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: 8 generations back to K930530 (1995). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202648: Biofeedback Nerve and Muscle Stimulator, Shenzhen Konmed Technology Co., Ltd. (2020) Summary page 4.

## 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 in women and to maintain urinary continence in women.

Source page: https://510kreport.com/device/K220161
Methodology: https://510kreport.com/methodology