# K201290: Medline DeNovo 4Pro Electrical Stimulation Device

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Sep 21, 2020 after 130 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.
- K053434: Myotrac Infiniti Electrical Stimulator, Thought Technology, Ltd. (2006) Summary page 5.

## Most influential descendants
- K243079: NeuroTrac® MyoPlus Pro (MYO120U) (2025), 0 descendants of its own
- K213043: Levator Elite (Model LE9011) (2022), 0 descendants of its own

## Indications for use
For EMG mode: - Relaxation muscle training and muscle re-education For NMES (also known as STIM) mode: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion - Muscle Re-Education For TENS mode: - Symptomatic relief and management of chronic (long-term), intractable pain - Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain For EMG Triggered Stimulation (ETS) mode (nonimplanted electrical continence device only): - 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 (abdominal or gluteal) For FES - Helps to relearn voluntary motor functions of the extremities

Source page: https://510kreport.com/device/K201290
Methodology: https://510kreport.com/methodology