# K202648: Biofeedback Nerve and Muscle Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Konmed Technology Co., Ltd.
- Decided: Dec 8, 2020 after 88 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K930530 (1995). 24 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080950: Stiwell MED4, Otto Bock, Austria GmbH (2009) Summary page 5.

## Most influential descendants
- K222201: Biological Feedback and Stimulation System (2022), 0 descendants of its own
- K220161: Biofeedback Nerve and Muscle Stimulator (2022), 0 descendants of its own

## Indications for use
As a powered muscle stimulator the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions: -Relaxation of muscle spasm *Prevention or retardation of disuse atrophy -Increasing local blood circulation -Muscle re-education -Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis -Maintaining or increasing range of motion As a biofeedback device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions: -Biofeedback, relaxation and muscle re-education purposes As a nonimplanted electrical continence device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions: -Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles. -Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles.

Source page: https://510kreport.com/device/K202648
Methodology: https://510kreport.com/methodology