(257 days)
No
The document does not mention AI, ML, or any related concepts like neural networks, deep learning, or adaptive algorithms that would typically indicate the presence of AI/ML. The device description focuses on standard electrical stimulation technology and software for parameter adjustment and training plan management.
Yes
The device is explicitly indicated for "adjunctive therapy in the treatment of medical diseases and conditions" and lists several specific therapeutic uses such as "Relaxation of muscle spasms" and "Helps to relearn voluntary motor functions."
No
- The device is described as a neuromuscular electrical stimulator and a functional electrostimulator, designed to treat conditions like muscle spasms, disuse atrophy, and to help re-learn motor functions. It generates electrical impulses for therapeutic purposes. There is no mention of the device analyzing data or providing a diagnosis.
No
The device description explicitly states it is a "portable functional electrostimulator with 6 channels" and a "battery-powered, wireless device," indicating it includes hardware components beyond just software.
Based on the provided information, the TrainFES advanced device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe a device that applies electrical stimulation to the body for therapeutic purposes related to muscles and nerves. This is a form of in vivo treatment (acting on a living organism).
- Device Description: The description reinforces that the device generates electrical impulses to stimulate musculature.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly treat the body itself. The TrainFES advanced is a therapeutic device that interacts directly with the patient's body.
N/A
Intended Use / Indications for Use
For Prescription and Home Use by prescription from a medical professional:
The TrainFES advanced 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, TrainFES advanced 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 an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions:
- Helps to relearn voluntary motor functions of the extremities.
Product codes
IPF, GZI
Device Description
TrainFES Advanced is a portable functional electrostimulator with 6 channels designed for use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient. This device generates electrical impulses to stimulate the musculature of paralyzed seqments and facilitate both the relearning of movement and neuromodulation of tone.
TrainFES Advanced is a battery-powered, wireless device, configurable from the TRAINFES App, available for Smartphone and Tablets, which allows you to adjust different parameters and follow a training plan from your smartphone. Session settings can be retrieved from the PC or Cloud.
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
TrainFES' Advanced intended population is anybody aged 22 or over.
Intended User / Care Setting
Environments of use: TrainFES Advanced devices can be used by both therapists and patients, in the clinic, hospitals or at home.
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)
Non-Clinical Testing:
- IEC 60601-1 Medical electrical equipment Part 1: General requirements for ● basic safety and essential performance.
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic
- disturbances Requirements and tests. ●
- IEC 60601-2-10 Medical electrical equipment Part 2: Particular requirements ● for the basic safety and essential performance of nerve and muscle stimulators.
- IEC 60601-1-11 Medical electrical equipment-Part 1-11: General ● requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 62133-2 Secondary cells and batteries containing alkaline or other . non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications.
- IEC 62304 Medical device software Software life cycle processes. ●
- IEC 62366 Applying Human Factors and Usability Engineering to Medical ● Device.
- ISO 14971 Medical devices Application of risk management to medical . devices.
No clinical testing was performed in support of this submission.
Key results: The TrainFES Advanced device meets the requirements of IEC 60601-1, IEC 60601-2-10, IEC60601-1-2 and IEC 60601-1-11. The bench test and safety report documentation provided in this presentation demonstrates that possible differences in their technological characteristics do not raise new safety or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 5, 2025
Biomedical Devices Spa % Juan Tezak Consultant Compliance 4 Devices 118 W Prive Cr. Delray Beach, Florida 33445
Re: K241488
Trade/Device Name: TrainFES Advanced Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF. GZI Dated: May 24, 2024 Received: May 24, 2024
Dear Juan Tezak:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Heather L. Dean -S
for Amber Ballard, PhD Assistant Director 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
3
Indications for Use
Submission Number (if known)
K241488
Device Name
TrainFES Advanced
Indications for Use (Describe)
For Prescription and Home Use by prescription from a medical professional:
The TrainFES advanced 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, TrainFES advanced 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 an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions:
- Helps to relearn voluntary motor functions of the extremities.
TrainFES' Advanced intended population is anybody aged 22 or over.
Environments of use: TrainFES Advanced devices can be used by both therapists and patients, in the clinic, hospitals or at home.
Platform: TrainFES 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) |
|---|---|
| -------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
510(k) Summary K241488 Prepared July 03, 2024
| I) | Applicant
Submitter
Address | Biomedical Devices Spa
Camino El Alba 8760, of 903 Las
Condes RM Chile |
|------|-----------------------------------|------------------------------------------------------------------------------|
| | Contact
Telephone
E-mail | Mr. Matias Hosiasson
+56 998 954326
matias@trainfes.com |
| II) | Device
Trade Name | TrainFES Advanced |
| | Common Name | External functional neuromuscular stimulator |
| | Classification Name | Stimulator, Neuromuscular, External Functional |
| | Regulation Number | 890.5850 IPF / 882.5810 GZI |
| | Product Code | IPF, GZI |
| III) | Predicate Device
510(k) Number | K210002 |
| | Applicant | EGZOTech Sp. Z.o.o |
| | Trade Name | Stella BIO |
Power Muscle Stimulator
876.5320 882.5810
NYN
890.5850 / 882.5890 / 882.5050 /
IPF, GZJ, HCC, GZI, KPI, NGX, NUH,
Classification Name
Regulation Number
Product Code
5
IV) Indication For Use
For Prescription and Home Use by prescription from a medical professional: The TrainFES advanced 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, TrainFES advanced 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 an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions: Helps to relearn voluntary motor functions of the extremities. TrainFES' Advanced intended population is anybody aged 22 or over.
Environments of use: TrainFES Advanced devices can be used by both therapists and patients, in the clinic, hospitals or at home.
Platform: TrainFES is a battery-powered, wireless device, accessible through software.
V) Device Description
TrainFES Advanced is a portable functional electrostimulator with 6 channels designed for use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient. This device generates electrical impulses to stimulate the musculature of paralyzed seqments and facilitate both the relearning of movement and neuromodulation of tone.
TrainFES Advanced is a battery-powered, wireless device, configurable from the TRAINFES App, available for Smartphone and Tablets, which allows you to adjust different parameters and follow a training plan from your smartphone. Session settings can be retrieved from the PC or Cloud.
VI) Comparison of Technological Characteristics
| Basic Device Characteristics | |||
|---|---|---|---|
| Characteristics / | |||
| Specification | TrainFES Advanced | Stella BIO | Difference |
| 510(k) Number | K241488 | K210002 | N/A |
| FDA product code | IPF, GZI | IPF, GZJ, HCC, GZI, KPI, | |
| NGX, NUH, NYN | N/A | ||
| Manufacturer | Biomedical Devices Spa | EGZO Tech | N/A |
6
| Classification | Class II | Class II | Same |
|---|---|---|---|
| Prescription or OTC | Prescription and Home Use | Prescription and Home Use | Same |
| Environment of Use | Clinics, hospitals and home environments | Clinics, hospitals and home environments | Same |
| Indications for use | For Prescription and Home Use by prescription from a medical professional: | ||
| The TrainFES advanced 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, TrainFES advanced 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 an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions:
• Helps to relearn voluntary motor functions of the extremities. | 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. | Similar Note 1 |
| | TrainFES' Advanced
intended population is
anybody aged 22 or over.
Environments of use:
TrainFES Advanced
devices can be used by
both therapists and
patients, in the clinic,
hospitals or at home.
Platform: TrainFES is a
battery-powered, wireless
device, accessible through
software. | 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. | |
| Power Source | Battery: Li-Ion 3,7V
(4000mAh) | Battery pack Li-Ion 7,4V | Different
Note 2 |
| Method of Line
Current Isolation | N/A (Battery) | N/A (Battery) | Same |
| | | | |
| Patient leakage
current (Normal
condition, μA) | N/A
Battery Operated Device
(