NuEra Tight Family, EMS Model

K201239 · Bios S.R.L. · NGX · Dec 31, 2020 · Physical Medicine

Device Facts

• Record ID: K201239
• Device Name: NuEra Tight Family, EMS Model
• Applicant: Bios S.R.L.
• Product Code: NGX · Physical Medicine
• Decision Date: Dec 31, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuEra Tight Family, EMS Model, is intended for: - improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen; - strengthening, toning and firming of buttocks, thighs and calves; - improvement of muscle tone and firmness, for strengthening muscles in arms.

Device Story

NuEra Tight Family, EMS Model, is a powered muscle stimulator using electromagnetic fields to induce electrical currents in muscles. Device comprises a main unit with a touch screen interface and two EMS handpieces (small and large) for treating various body parts. Operation involves generating intense magnetic fields to initiate nerve action potentials, resulting in muscle contraction. Used in clinical settings by healthcare providers to strengthen, tone, and firm muscles in the abdomen, buttocks, thighs, calves, and arms. The device is prescription-only. It features patient override controls and firmware-based control of stimulation parameters (1-150 Hz frequency, biphasic sinusoidal waveform). Benefits include non-invasive muscle conditioning and improved muscle tone.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through electrical safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10), software verification (IEC 62304), and functional testing against technical specifications. Biocompatibility assessed per ISO 10993-1; device has no direct skin contact.

Technological Characteristics

Powered muscle stimulator; generates electromagnetic fields via magnetic coils in handpieces. Materials: steel and injection-molded plastics. Energy: magnetic field (0.5–2.0 T). Waveform: biphasic sinusoidal. Connectivity: touch screen interface, firmware-controlled. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10, IEC 62304, ISO 14971, ISO 10993-1.

Indications for Use

Indicated for improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen; strengthening, toning, and firming of buttocks, thighs, and calves; and improvement of muscle tone and firmness for strengthening arm muscles.

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

• BTL 799-2L (K190456)

Submission Summary (Full Text)

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December 31, 2020

Bios s.r.l. Maurizio Bianchi Head of QA/RA Via Guido Rossa 10/12 Vimodrone, MI 20090 Italy

Re: K201239

Trade/Device Name: NuEra Tight Family, EMS Model Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 5, 2020 Received: October 8, 2020

Dear Maurizio Bianchi:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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-devices/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 (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).

Sincerely,

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K201239

Device Name NuEra Tight Family, EMS Model

***Indications for Use (Describe)***

| The NuEra Tight Family, EMS Model, is intended for: | |
|-----------------------------------------------------|--|
|-----------------------------------------------------|--|

- improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen;
- strengthening, toning and firming of buttocks, thighs and calves;

- improvement of muscle tone and firmness, for strengthening muscles in arms.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------|
| <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(k) Summary

| Contact Details | |
|-----------------------|-----------------------------------------------------------------------|
| 510(k) Number | K201239 |
| 510(k) Type | Traditional |
| Applicant Information | Bios s.r.l.<br>Via Guido Rossa, 10/12<br>20090 Vimodrone (MI) – Italy |
| Contact | Dr Eliana Russo |
| Date Prepared | 24 June 2020 |
| Device Name(s): | NuEra Tight Family, EMS Model |
| Model Refs | APMD151 |
| Common Name | Powered Muscle Stimulator |
| Regulatory Class | Class II |
| Product Codes | NGX |
| Regulation Names | Stimulator, muscle, powered, for muscle conditioning |

| Predicate Device for EMS Treatments | | | |
|-------------------------------------|---------------|----------------------------------------|----------------------|
| K190456 | NGX, 890.5850 | Powered Muscle Stimulator (BTL 799-2L) | BTL Industries, Inc. |

# Device Description

NuEra Tight Family, EMS Model, is a family of devices designed to:

- produce an electromagnetic field that induces electrical current in the muscles. By muscle stimulation, the system helps to strengthen, tone and firm the abdomen, buttocks, thighs and calves.
The device belonging to the NuEra Tight Family, EMS Model, generates an intense magnetic field which is used to stimulate muscles trough two EMS handpieces, one small and one large, which can treat body parts of different sizes.

# Indications for Use

The NuEra Tight Family, EMS Model, is intended for:

- . Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen;
- ı Strengthening, toning and firming of buttocks, thighs and calves;
- . Improvement of muscle tone and firmness, for strengthening muscles in arms.

# Predicate Device Comparison

The product specification, functionality, indications for use, and treatment parameters of the NuEra Tight Family, EMS Model, are the same or very similar to the legally marketed predicate and reference devices.

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For the electromagnetic stimulation function, the subject device and predicate device have many identical, similar or substantially equivalent properties or features. No differences that could affect safety or effectiveness have been identified, as indicated in Table 1.

| Table 1: Predicate device comparison table – NuEra Tight Family, EMS Model – Electromagnetic Stimulation | | | |
|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Feature | Subject device | Predicate device | Similarity |
| Device name | NuEra Tight Family (EMS Model) | BTL 799-2L | N/A |
| Device Manufacturer | Bios S.r.l. | BTL Industries, Inc. | N/A |
| 510(K) Number | K201239 | K190456 | N/A |
| Product Code | NGX - Stimulator, Muscle, Powered | NGX - Stimulator, Muscle, Powered | Same |
| Regulation | 21 CFR 890.5850 | 21 CFR 890.5850 | Same |
| Indications for Use | The NuEra Tight Family (EMS Model) is intended:<br>• for improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen;<br>• for strengthening, toning and firming of buttocks, thighs and calves;<br>• for improvement of muscle tone and firmness, for strengthening muscles in arms. | BTL 799-2L is indicated to be used for:<br>• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.<br>• Strengthening, toning and firming of buttocks, thighs and calves.<br>• Improvement of muscle tone and firmness, for strengthening muscles in arms. | Same |
| Principle of action | Initiating action potential of nerves results in muscle contraction. | Initiating action potential of nerves results in muscle contraction. | Same |
| Clinical use | Prescription Use | Prescription Use | Same |
| Electrical Protection | Class I type BF | Class I type BF | Same |
| User Interface | Touch Screen | Touch Screen | Same |
| Firmware Controlled | Yes | Yes | Same |
| Type of energy | Magnetic Field | Magnetic Field | Same |
| Number of outputs | 2 | 2 | Same |
| Number of magnetic<br>coils in the applicator | 1 | 1 | Same |
| Magnetic Field Intensity | Large HP: 0.5 – 1.8 T ± 20% | BTL 299-6 applicator: 0.5 - 1.8 T ± 20% | Same |
| | Small HP: 0.7 – 2.0 T ± 20% | BTL 299-7 applicator: 0.7 - 2.0 T ± 20% | Same |
| Pulse Repetition Rate | 1-150 Hz | 1-150 Hz | Same |
| Pulse Duration | Large HP: 280 ± 20% µs | BTL 299-6 applicator: 280 ± 20% µs | Same |
| | Small HP: 190 ± 20% µs | BTL 299-7 applicator: 190 ± 20% µs | Same |
| Therapy Time | Up to 60 min | Up to 60 min | Same |
| Characteristics | Bios Device | Predicate Device | Notes |
| Device name | NuEra Tight Family (EMS Model) | BTL 799-2L | N/A |
| Device Manufacturer | Bios s.r.l. | BTL Industries, Inc. | N/A |
| 510(K) Number | K201239 | K190456 | N/A |
| Power Source(s)<br>- Method of Line<br>Current Isolation<br>Patient Leakage<br>Current<br>- Normal condition<br>- Single fault condition | IEC 60601-1 compliant<br>< 0,1 μΑ<br>< 5 μΑ | IEC 60601-1 compliant<br>< 0,1 μΑ<br>< 5 μΑ | N/A |
| Average DC current<br>through electrodes<br>when device is on but<br>no pulses are being<br>applied (µA) | N/A | N/A | No electrodes.<br>Applicators are<br>not connected<br>to patient. |
| Number of Output<br>Modes | 1 | 1 | N/A |
| Number of Output<br>Channels<br>- Synchronous or<br>Alternating? | 2<br>Synchronous | 2<br>Synchronous | No electrodes.<br>Applicators are<br>not connected<br>to patient. |
| - Method of Channel<br>Isolation | N/A | N/A | |
| Regulated Current or<br>Regulated Voltage? | Regulated voltage | Regulated Voltage | N/A |
| Software /Firmware<br>/Microprocessor<br>Control? | Yes | Yes | N/A |
| Automatic Overload<br>Trip? | N/A | N/A | No electrodes.<br>Applicators are<br>not connected<br>to patient. |
| Automatic No-Load<br>Trip? | N/A | N/A | No electrodes.<br>Applicators are<br>not connected<br>to patient. |
| Automatic Shut Off? | No | Not available | N/A |
| Patient Override<br>Control? | Yes | Not available | N/A |
| Indicator Display:<br>- On/Off Status?<br>- Low Battery?<br>- Voltage/Current<br>Level? | Yes<br>N/A<br>No | Yes<br>N/A<br>No | N/A |
| Timer Range (minutes) | Up to 30 minutes | Up to 30 minutes | N/A |
| Compliance with<br>Voluntary Standards?<br>(If yes, specify) (If yes,<br>specify) | N/A | N/A | N/A |
| Compliance<br>with 21 CFR 898? | N/A | N/A | N/A |
| Weight | 100 kg | Not available | N/A |
| Dimensions (in.) [W x<br>H x D] | 1350x560x710 mm<br>(53x22x28 in) | 580x1380x580 mm (23x55x23 in) | N/A |
| Housing Materials and<br>Construction | Steel and Injection Molded<br>Plastics | Steel and Injection Molded Plastics | N/A |

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#### Table 2: Basic Unit Characteristics

This section is intended to describe basic unit characteristics. The parameters listed are assumed to be independent of the selected output mode. If this is not the case, or if the information is not applicable to the device, an explanation should be provided. If a specific parameter is not applicable (N/A), this should be noted.

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| Table 3: Output Specifications | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| An output mode is defined (for reporting purposes) as a<br>version of a waveform produced by the unit. For example,<br>biphasic symmetrical, biphasic asymmetrical, and<br>monophasic would all be considered separate output<br>modes. A copy of the following information should be<br>completed for each output mode. If a specific parameter is<br>not applicable (N/A), this should be noted. | | | |
| | | Unique output mode.<br>No electrical output delivered to the body for this EMS<br>technology | |
| Characteristics | Bios Device | Predicate Device | Notes |
| Waveform (e.g.,<br>pulsed monophasic,<br>biphasic) | Biphasic | Biphasic | N/A |
| Shape (e.g.,<br>rectangular, spike,<br>rectified sinusoidal) | Sinusoidal | Sinusoidal | N/A |
| Maximum Output<br>Voltage (specify units) | N/A | N/A | No electrodes.<br>Applicators are<br>not connected<br>to patient. |
| Maximum Output<br>Current (specify units) | N/A | N/A | No electrodes.<br>Applicators are<br>not connected<br>to patient. |
| Pulse Width (specify<br>units) | Large HP: 280 ± 20% µs | BTL 299-6 applicator: 280 ± 20% µs | N/A |
| | Small HP: 190 ± 20% µs | BTL 299-7 applicator: 190 ± 20% µs | N/A |
| Frequency (Hz) | 1-150 Hz | 1-150 Hz | N/A |
| For interferential<br>modes only:<br>- Beat Frequency (Hz) | N/A | N/A | N/A |
| For multiphasic<br>waveforms only:<br>- Symmetrical phases?<br>- Phase Duration<br>(include units)<br>(state range, if<br>applicable)<br>(both phases, if<br>asymmetrical) | Yes | Yes | N/A |
| Net Charge (mC per pulse) | | | |
| Net Charge (mC per pulse) | N/A | N/A | No electrodes.<br>Applicators are not connected to patient. |
| Maximum Phase Charge, (mC) | N/A | N/A | No electrodes.<br>Applicators are not connected to patient. |
| Maximum Current Density (mA/cm²) | N/A | N/A | No electrodes.<br>Applicators are not connected to patient. |
| Maximum Average Current | N/A | N/A | No electrodes.<br>Applicators are not connected to patient. |
| Maximum Power Density (W/cm²) (using smallest electrode conductive surface area) | N/A | N/A | No electrodes.<br>Applicators are not connected to patient. |
| Burst Mode (i.e., pulse trains)<br>a. Pulses per burst<br>b. Bursts per second<br>c. Burst duration (seconds)<br>d. Duty Cycle [Line (b) x Line (c)] | N/A | N/A | N/A |
| ON Time (seconds) | N/A | N/A | N/A |
| OFF Time (seconds) | N/A | N/A | N/A |
| Additional Features (if applicable) | N/A | N/A | N/A |

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# Performance Data

#### Electrical safety and electro-magnetic compatibility

The NuEra Tight Family, EMS Model, has been tested and is in compliance with:

- . 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 60601-1-6; Medical Electrical Equipment Part 1-6: General Requirements For Basic Safety And ● Essential Performance - Collateral Standard: Usability;
- IEC 60601-2-10/A1; Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators;
- IEC 62304; Medical Device - Software Life Cycle Processes;
- ISO 14971; Medical Devices Application Of Risk Management To Medical Devices .

# Software Verification and Validation

In addition to the electrical safety testing performed, software verification was conducted to FDA regulations, standards and guidance document requirements. The results of this testing conclude the software has met these requirements. Design verification was also performed on the NuEra Tight Family, EMS Model, in compliance with internal design control procedures. The results of this testing conclude the NuEra Tight Family, EMS Model, is determined to be safe and effective.

# Functional Testing

Functional tests have been performed to confirm that the performance of the NuEra Tight Family, EMS Model, devices are aligned with the device technical specifications.

#### Biocompatibility

Based on the type and duration of body contact, existing biocompatibility data has been assessed in accordance with ISO 10993-1:2018 (FDA standards recognition # 2-258) and FDA guidance document 'Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": Guidance for Industry and Food and Drug Administration Staff', 16 June 2016.

The NuEra Tight Family, EMS Model, has no contact with the skin of the treated patients.

# Conclusion

Based upon the indications for use and known technical information provided in this pre-market notification, the NuEra Tight Family, EMS Model, devices has been shown to be substantially equivalent to currently marketed predicate and reference devices. Any differences are considered minor and do not raise new issues of the safety and effectiveness of the NuEra Tight Family, EMS Model, devices when compared to the predicate devices.