# K222201: Biological Feedback and Stimulation System

- Pathway: 510(k) (Traditional)
- Applicant: Medlander Medical Technology, Inc.
- Decided: Oct 21, 2022 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: 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 5.

## Indications for use
As a powered muscle stimulator the Biological Feedback and Stimulation System is indicated for the following conditions: Relaxation of muscle spasm Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education [mmediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion As a biofeedback device the Biological Feedback and Stimulation System is indicated for the following conditions: Biofeedback, relaxation and muscle re-education purposes As a nonimplanted electrical continence device the Biological Feedback and Stimulation System 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 detrusor muscles through reflexive mechanisms and strengthening of pelvic floor muscles. [ncontinence 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/K222201
Methodology: https://510kreport.com/methodology