(270 days)
Not Found
No
The document describes a standard neuromuscular electronic stimulator, biofeedback device, and incontinence device. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The software description focuses on parameter adjustment and data retrieval, not intelligent processing.
Yes
The Stella BIO is explicitly described as a "neuromuscular electronic stimulator" and its intended uses include treatment of medical diseases and conditions such as muscle spasms, pain relief, and urinary incontinence. These applications clearly categorize it as a therapeutic device.
No
The device is marketed as a neuromuscular electronic stimulator, non-implantable incontinence device, and biofeedback device. Its stated indications for use are for therapy, relief, re-education, and treatment of various conditions, rather than for diagnosing conditions. While it can assess EMG activity (a diagnostic tool), its primary function as described is therapeutic/rehabilitative.
No
The device description explicitly states "Stella BIO is a single presentation device (one hardware) with a single software". It also mentions it is a "battery-powered, wireless device". This indicates the presence of physical hardware components beyond just software.
Based on the provided information, the Stella BIO device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed for the Stella BIO are all related to neuromuscular stimulation, pain relief, biofeedback, functional neuromuscular stimulation, and incontinence treatment. These are all therapeutic or rehabilitative applications that involve interacting directly with the patient's body.
- Device Description: The description confirms it's a "neuromuscular electronic stimulator, non-implantable incontinence device and biofeedback device." This aligns with the therapeutic nature of the device.
- Lack of In Vitro Activities: An IVD is a medical device that is used to perform tests on samples taken from the human body (such as blood, urine, tissue) to provide information about a person's health. The Stella BIO does not perform any such tests on biological samples. Its function is to deliver electrical stimulation or provide biofeedback based on physiological signals.
Therefore, the Stella BIO falls under the category of a therapeutic or rehabilitative medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
IPF, GZJ, HCC, GZI, KPI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Stella BIO Prescription and Home Use by prescription from a medical professional can be used on adults aged 22 yrs and older.
Intended User / Care Setting
Intended User: medical professional / patient
Care Setting: Clinics, hospital and home environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing information demonstrating safety and effectiveness of the Stella BIO device in the intended environment of use is supported by testing that was conducted in accordance with the FDA June 1999 Draft "Guidance Document for Powered Muscle Stimulator 510(k)s", CDRH, which outlines Technological Characteristics, Electrode Lead Wires and Patient cables performance standards and Electromagnetic Compatibility (EMC) requirements.
The following testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate device:
- Electrical safety and electromagnetic compatibility (EMC)
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-2-10
- IEC 60601-1-11
- IEC 62133-2
- ANSI/AAMI NS4
- Wi-Fi and Bluetooth testing
- FCC CFR47 Part 15C(2017)
- Software
- IEC 62304
- Usability
- IEC 62366
- Risk analysis
- ISO 14971
- Biocompatibility
- ISO 10993-1 (Cytotoxicity, Sensitization and Irritation)
- Quality
- ISO 13485
- Additional standards
- IEC 62353
- EN 1041
- ISO 15223-1
- 93/42/EEC Annex II
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that Stella BIO tested met all relevant requirements of the aforementioned tests.
Software verification and validation testing were conducted and supported by documentation according to the FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The details of the software license for Prescription and Home Use by prescription from a medical professional software license were clearly demonstrated in the software documentation and the risks related to the software products were mitigated. The software for this device was considered as a "Moderate" level of concern. The proposed subject device is in compliance with IEC 62304 test standard requirements.
Summary conclusion: Stella BIO device is substantially equivalent as the predicate device Stiwell med4 Powered Muscle Stimulator.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
October 1, 2021
EGZOTech Sp. z o. o. % Vaibhav Rajal Official Correspondent for EGZOTech Sp. z o.o. mdi Consultants. Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K210002
Trade/Device Name: Stella Bio Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF. GZJ. HCC. GZI. KPI Dated: September 3, 2021 Received: September 3, 2021
Dear Vaibhav Rajal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Patrick Antkowiak, PhD Assistant Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210002
Device Name STELLA BIO
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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Image /page/4/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, triangular shape on the left, and the text "EGZO Tech" on the right. The triangular shape is made up of three curved lines that intersect in the center. The text is in a bold, sans-serif font, with "EGZO" in a larger font size than "Tech".
510(k) SUMMARY
The assigned 510(k) number is: K210002
Submitter's Identification:
| Submitter's Name and Address: | EGZOTech Sp. Z.o.o.
Romualda Traugutta 6h
44-100 Gliwice, Poland |
|-------------------------------|------------------------------------------------------------------------|
| Contact Person: | Dr. Michal Mikulski
Chief Executive Officer |
| Telephone: | +48 32 750 49 45 |
| Email: | fda@egzotech.com |
| Date: | October 1, 2021 |
Name of the Device:
Stella BIO Trade Name:
FDA Product Codes, Common Name, Regulation Description and Regulation Number:
| FDA Product
Code | Common Name | Regulation Description | Regulation
Number |
|---------------------|---------------------------------------------------------------|----------------------------------------------------------------|----------------------|
| IPF | Stimulator, Muscle, Powered | Powered muscle stimulator | 890.5850 |
| GZJ | Stimulator, Nerve,
Transcutaneous, For Pain Relief | Transcutaneous electrical nerve
stimulator for pain relief. | 882.5890 |
| HCC | Device, Biofeedback | Biofeedback device. | 882.5050 |
| GZI | Stimulator, Neuromuscular,
External Functional | External functional neuromuscular
stimulator. | 882.5810 |
| KPI | Stimulator, Electrical, Non-
Implantable, For Incontinence | Nonimplanted electrical
continence device. | 876.5320 |
Information for the 510(k) Cleared Device (Predicate Device):
Predicate Device for Prescription and Home Use by prescription from a medical professional:
| 510(k)
number | Predicate
device | Manufacturer | Regulation
Number | Product Code | Clearance Date |
|------------------|---------------------|----------------------|----------------------|--------------|----------------|
| K080950 | Stiwell med4 | Otto Bock Healthcare | 890.5850 | IPF, GZJ, | 2009-04-02 |
EGZOTech Sp. z o.o., ul. Romualda Traugutta 6H, 44-100 Gliwice, Poland Telephone: 0048 32 750 49 45 ; e-mail: office@egzotech.com ; https://egzotech.com; REF: 001 510(k) Summary 4 dated 2021-05-07 09:35
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Image /page/5/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, triangular shape on the left, and the text "EGZO Tech" on the right. The triangular shape is made up of three curved lines that intersect in the center, forming a sort of pinwheel design. The text is in a bold, sans-serif font.
| Product GmbH
Kaiserstrasse 39
1070 Vienna
| Austria | HCC, GZI, KPI |
|---|---|
| ------------------------------------------------------------ | --------------- |
Applicable FDA Product Codes, Common Name, Regulation Description and Regulation Number for the Predicate Device:
| FDA Product
Code | Common Name | Regulation Description | Regulation
Number |
|---------------------|---------------------------------------------------------------|----------------------------------------------------------------|----------------------|
| IPF | Stimulator, Muscle, Powered | Powered muscle stimulator | 890.5850 |
| GZJ | Stimulator, Nerve,
Transcutaneous, For Pain Relief | Transcutaneous electrical nerve
stimulator for pain relief. | 882.5890 |
| HCC | Device, Biofeedback | Biofeedback device. | 882.5050 |
| GZI | Stimulator, Neuromuscular,
External Functional | External functional neuromuscular
stimulator. | 882.5810 |
| KPI | Stimulator, Electrical, Non-
Implantable, For Incontinence | Nonimplanted electrical
continence device. | 876.5320 |
Device Description:
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.
6
Image /page/6/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized symbol on the left and the text "EGZO Tech" on the right. The symbol is a geometric shape with three curved lines intersecting at a central point. The text is in a bold, sans-serif font, with "EGZO" in a darker shade than "Tech".
Indications for Use
For Prescription and Home Use by prescription from a medical professional:
The Stella BIO is a neuromuscular electrical 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.
Comparison to the 510(k) Cleared Devices (Predicate Devices)
| Basic Device Characteristics | |||
|---|---|---|---|
| Characteristics / | |||
| Specification | New Device | Predicate | Difference |
| 510(k) Number | K210002 | K080950 | N/A |
| Manufacturer | EGZOTech | Otto Bock | N/A |
| Device Name, | |||
| Model | Stella BIO | STIWELL med4 | N/A |
| Prescription or | |||
| OTC | Prescription and Home Use | Prescription | Same |
| Product codes | IPF, GZJ, HCC, GZI, KPI | IPF, GZJ, HCC, GZI, KPI | Same |
| Classification | Class II | Class II | Same |
| Indications For Use | |||
| Statement | For Prescription and Home | ||
| Use by prescription from a | |||
| medical professional: | For Prescription: | ||
| 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 | The STIWELL med4 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 powered muscle
stimulator the STIWELL med4
is indicated for the following
conditions: - Relaxation of muscle spasms,
- 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 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 | As a transcutaneous electrical
nerve stimulator for pain relief
the STIWELL med4 is
indicated for the following
conditions: - Symptomatic relief and
management of chronic (long-
term), intractable pain, - Adjunctive treatment in the
management of post-surgical | |
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Image /page/7/Picture/0 description: The image shows the logo for EGZOTech. The logo consists of a stylized symbol on the left and the text "EGZOTech" on the right. The symbol is a geometric shape with three curved lines intersecting at a central point. The text is in a bold, sans-serif font.
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| pain. | pain and post traumatic acute
pain. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| As a biofeedback device Stella
BIO is indicated for:
- Biofeedback, relaxation and
muscle re- education
purposes. | As a biofeedback device the
STIWELL med4 is indicated for: - Biofeedback, relaxation and
muscle re- education purposes. |
| As an external functional
neuromuscular stimulator
Stella BIO is indicated for the
following conditions: - Helps to relearn voluntary
motor functions of the
extremities. | As an external functional
neuromuscular stimulator the
STIWELL med4 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. | As a non-implanted electrical
continence device the
STIWELL med4 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. | |
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Image /page/9/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, abstract symbol on the left, resembling three interconnected shapes forming a triangular design. To the right of the symbol is the text "EGZO Tech", with "EGZO" in a bold, sans-serif font and "Tech" in a lighter weight font.
| Environment of
Use | Clinics, hospital and home
environments | Clinics, hospital and home
environments | Same |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|---------------------|
| Patient population | Adults 22 yrs and older | Adults | Same |
| Power Source | Battery Pack Li-Ion 7,4 V | Battery Pack Li-lon
11,1 V | Different
Note 1 |
| Method of Line
Current Isolation | N/A (Battery) | Medical Class II Power Adapter
- Mascot (12,6VDC-15,1W) | Different
Note 1 |
| Patient Leakage
Current
(normal condition,
μΑ ) | N/A
Battery Operated Device
(