Search Results

For Prescription and Home Use by prescription from a medical professional:

The Stella BIO is a neuromuscular electronic stimulator indical 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.

The Stella BIO is a neuromuscular electronic stimulator, non-implantable incontinence device and biofeedback device, designed for stationary use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient.

Stella BIO is a single presentation device (one hardware) with a single software for Prescription and Home Use by prescription from a medical professional.

For the Prescription and Home Use by prescription from a medical professional Software License, the medical professional has the ability to adjust, monitor and progress the therapy. This License comes with two User Manuals:

• User Manual for the medical professionals (including instructions on how to adjust parameters ● of the programs and prescribe exercises for patients)
• User Manual for the patient (including instruction on how to use programs prescribed and adjusted by the medical professional)

The Stella BIO is a battery-powered, wireless device, accessible through software on a mobile device (PC, tablet or smartphone). Statistics reqarding the completed treatment can be retrieved from the PC.

In order to gain a proper understanding of Stella BIO, it is important to read the manual before beginning to use the Stella BIO.

This document is a 510(k) summary for the Stella BIO device, which is a neuromuscular electronic stimulator, non-implantable incontinence device, and biofeedback device. The purpose of this summary is to demonstrate that the Stella BIO device is substantially equivalent to a legally marketed predicate device, the Stiwell med4 (K080950).

Key Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence by comparing the Stella BIO to its predicate device across various "designations" (Powered Muscle Stimulator, Functional Electrical Stimulation, Transcutaneous Electrical Nerve Stimulation, Incontinence Programs, Biofeedback). Instead of defining explicit acceptance criteria with numerical targets as one might for a diagnostic AI, the acceptance criteria here are implicitly met by demonstrating that any differences between the new device and the predicate device, or adherence to relevant voluntary standards (IEC, ANSI/AAMI, FDA guidance), do not raise new questions of safety or effectiveness.

Therefore, the "acceptance criteria" table below is constructed by extracting the key comparative metrics and the conclusions drawn regarding their impact on safety and effectiveness.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance:

Ask a specific question about this device