# K210002: Stella Bio

- Pathway: 510(k) (Traditional)
- Applicant: Egzotech Sp. Z O. O.
- Decided: Oct 1, 2021 after 270 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.
1 later device descends from it; 1 cites it directly.
0 of 26 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
- K241488: TrainFES Advance (2025), 0 descendants of its own

## Indications for use
For Prescription and Home Use by prescription from a medical professional: The Stella BIO is a neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions As a powered muscle stimulator, Stella BIO is indicated for the following conditions: • 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. As a transcutaneous electrical nerve stimulator for pain relief, Stella BIO is indicated for the following conditions: • Symptomatic relief and management of chronic (long-term), intractable pain, • Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain. As a biofeedback device, Stella BIO is indicated for: • Biofeedback, relaxation, and muscle re- education. As an external functional neuromuscular stimulator, Stella BIO is indicated for the following conditions: • Helps to relearn voluntary motor functions of the extremities. As a non-implanted electrical continence device, Stella BIO 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. • Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as abdominal and the gluteus muscles. Patient population: Stella BIO Prescription and Home Use by prescription from a medical professional can be used on adults aged 22 yrs and older. Environments of Use: Clinics, hospital and home environments. Platform: Stella BIO is a battery-powered, wireless device, accessible through software.

Source page: https://510kreport.com/device/K210002
Methodology: https://510kreport.com/methodology