TrainFES Advance

K241488 · Trainfes · IPF · Feb 5, 2025 · Physical Medicine

Device Facts

• Record ID: K241488
• Device Name: TrainFES Advance
• Applicant: Trainfes
• Product Code: IPF · Physical Medicine
• Decision Date: Feb 5, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

TrainFES Advanced is a 6-channel, battery-powered, wireless functional electrostimulator. Used in clinics, hospitals, or home environments by patients and medical professionals. Device generates electrical impulses to stimulate paralyzed segments; facilitates movement relearning and neuromodulation of tone. Configured via smartphone/tablet app; session settings retrievable from PC or cloud. Output parameters (e.g., current, frequency, pulse width) are adjusted by the user/therapist via software. Output affects muscle contraction, aiding in physical therapy and rehabilitation. Benefits include improved motor function, circulation, and muscle maintenance.

Clinical Evidence

No clinical testing was performed in support of this submission. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), performance of nerve/muscle stimulators (IEC 60601-2-10), home healthcare environment requirements (IEC 60601-1-11), battery safety (IEC 62133-2), software lifecycle (IEC 62304), usability (IEC 62366), and risk management (ISO 14971).

Technological Characteristics

6-channel, battery-powered (Li-Ion 3.7V, 4000mAh) wireless stimulator. Housing: ABS plastic. Output: Regulated current, biphasic symmetrical rectangular waveforms. Pulse width: 50-400 µs; Frequency: 1-140 Hz. Connectivity: Bluetooth (FCC 15.2473). Standards: IEC 60601-1, 60601-1-2, 60601-2-10, 60601-1-11, 62133, 62304, 62366, ISO 14971. Software-controlled via smartphone/tablet app.

Indications for Use

Indicated for patients aged 22+ for relaxation of muscle spasms, prevention/retardation of disuse atrophy, increasing local blood circulation, post-surgical calf stimulation to prevent venous thrombosis, maintaining/increasing range of motion, muscle re-education, and relearning voluntary motor functions of extremities. Used under medical supervision.

Regulatory Classification

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.

Predicate Devices

• Stella BIO (K210002)

Reference Devices

• K080950

Submission Summary (Full Text)

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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"

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(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 ([e-mail]) or phone [phone] or 301-796-7100).

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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

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## 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)

| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|

X | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary K241488 Prepared July 03, 2024

| I) | Applicant<br>Submitter<br>Address | Biomedical Devices Spa<br>Camino El Alba 8760, of 903 Las<br>Condes RM Chile |
|------|-----------------------------------|------------------------------------------------------------------------------|
| | Contact<br>Telephone<br>E-mail | Mr. Matias Hosiasson<br>[phone]<br>[e-mail] |
| II) | Device<br>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<br>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

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#### 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 /<br>Specification | TrainFES Advanced | Stella BIO | Difference |
| 510(k) Number | K241488 | K210002 | N/A |
| FDA product code | IPF, GZI | IPF, GZJ, HCC, GZI, KPI,<br>NGX, NUH, NYN | N/A |
| Manufacturer | Biomedical Devices Spa | EGZO Tech | N/A |

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| 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:<br>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.<br><br>As a powered muscle stimulator, TrainFES advanced is indicated for the following conditions:<br>• Relaxation of muscle spasms<br>• Prevention or retardation of disuse atrophy<br>• Increasing local blood circulation<br>• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis<br>• Maintaining or increasing range of motion<br>• Muscle re-education<br><br>As an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions:<br>• 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.<br><br>As a powered muscle stimulator, Stella BIO is indicated for the following conditions:<br>• Relaxation of muscle spasms,<br>• Prevention or retardation of disuse atrophy,<br>• Increasing local blood circulation,<br>• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,<br>• Maintaining or increasing range of motion,<br>• Muscle re-education.<br><br>As a transcutaneous electrical nerve stimulator for pain relief, Stella BIO is indicated for the following conditions:<br>• Symptomatic relief and management of chronic (long-term), intractable pain,<br>• Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.<br><br>As a biofeedback device, Stella BIO is indicated for:<br>• Biofeedback, relaxation, and muscle re- education. | Similar Note 1 |
| | TrainFES' Advanced<br>intended population is<br>anybody aged 22 or over.<br><br>Environments of use:<br>TrainFES Advanced<br>devices can be used by<br>both therapists and<br>patients, in the clinic,<br>hospitals or at home.<br><br>Platform: TrainFES is a<br>battery-powered, wireless<br>device, accessible through<br>software. | As an external functional<br>neuromuscular stimulator,<br>Stella BIO is indicated for<br>the following<br>conditions:<br>• Helps to relearn voluntary<br>motor functions of the<br>extremities.<br><br>As a non-implanted<br>electrical continence<br>device, Stella BIO is<br>indicated for the following<br>conditions:<br>• Acute and ongoing<br>treatment of stress, urge or<br>mixed urinary incontinence<br>and where the following<br>results may improve<br>urinary control: inhibition of<br>the detrusor muscles<br>through reflexive<br>mechanisms<br>and strengthening of pelvic<br>floor muscles.<br>• Incontinence treatment<br>for assessing EMG activity<br>of the pelvic floor and<br>accessory muscles such as<br>abdominal and the gluteus<br>muscles.<br><br>Patient population: Stella<br>BIO Prescription and Home<br>Use by prescription from a<br>medical professional<br>can be used on adults<br>aged 22 yrs and older.<br>Environments of Use:<br>Clinics, hospital and home<br>environments.<br><br>Platform: Stella BIO is a<br>battery-powered, wireless<br>device, accessible through<br>software. | |
| Power Source | Battery: Li-Ion 3,7V<br>(4000mAh) | Battery pack Li-Ion 7,4V | Different<br>Note 2 |
| Method of Line<br>Current Isolation | N/A (Battery) | N/A (Battery) | Same |
| | | | |
| Patient leakage<br>current (Normal<br>condition, μA) | N/A<br>Battery Operated Device<br>(<100μA patient leakage) | N/A<br>Battery Operated Device<br>(<100μA patient leakage) | Same |
| Patient leakage<br>current (Single fault<br>condition, μA) | N/A<br>Battery Operated Device<br>(<100μA patient leakage) | N/A<br>Battery Operated Device<br>(<100μA patient leakage) | Same |
| Number of Output<br>Modes | 2 | 4 | Different<br>Note 3 |
| Software/<br>Microprocessor<br>control | Yes | Yes | Same |
| Automatic Overload<br>Trip | Yes | Yes | Same |
| Automatic No-Load<br>Trip | Yes | Yes | Same |
| Automatic Shut Off | Yes | Yes | Same |
| Patient Override<br>Control | Yes (Button) | Yes | Same |
| Indicator Display<br>On/Off Status | Yes (Led) | Yes | Same |
| Indicator Display<br>Low Battery | Yes | Yes | Same |
| Indicator Display<br>Voltage/Current<br>Level | Yes | Yes | Same |
| Standards | ISO 13485:2016<br>Bluetooth: Complies with<br>FCC 15.2473 (for U.S.)<br>regulations<br>IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>IEC 60601-1-11<br>IEC 62133<br>Compliance<br>IEC 62304:2015<br>IEC 62366 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>IEC 60601-1-11<br>IEC 62304<br>IEC 62366<br>IEC 62133<br>ANSI/AAMI NS4 | Different<br>Note 4 |
| Compliance with 21<br>CFR 898 | Yes | Yes | Same |
| Weight | 218 g | 112 g | Similar<br>Note 5 |
| Dimension | 130 x 79 x 33mm | 91.5 x 68.4 x 24 mm | Similar<br>Note 5 |
| Housing material<br>and Construction | ABS Plastic | Plastic (Injection Molded<br>ABS) | Same |
| Apply Part | BF | | |
| Powered Muscle Stimulator | | | |
| Characteristics /<br>Specification | TrainFES Advanced | Stella BIO | Difference |
| 510(k) Number | K241488 | K210002 | N/A |
| Manufacturer | Biomedical Devices Spa | EGZO Tech | N/A |
| Number of channels | 6 Channels | 8 Channels | Different<br>Note 1 PMS |
| Synchronous or<br>alternating | Alternating | Synchronous | Different<br>Note 2 PMS |
| Method of channel<br>isolation | Multiplexer | Multiplexer…