HI-EMT MAGSHAPE

K230024 · Beijing Sano Laser S&T Development Co.,Ltd · NGX · Sep 6, 2023 · Physical Medicine

Device Facts

• Record ID: K230024
• Device Name: HI-EMT MAGSHAPE
• Applicant: Beijing Sano Laser S&T Development Co.,Ltd
• Product Code: NGX · Physical Medicine
• Decision Date: Sep 6, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

HI-EMT MAGSHAPE is a noninvasive electromagnetic muscle stimulation device. It uses electromagnetic field energy delivered via handles to induce nerve action potentials, resulting in muscle contraction. The device is operated by a clinician in a professional setting using a color touch screen interface to control parameters like intensity and therapy time (up to 60 minutes). By stimulating muscle contractions, the device aims to improve muscle tone, firmness, and strength in the abdomen, buttocks, thighs, calves, and arms. It is intended for use as a prescription device.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility assessment of ABS materials per ISO 10993-1.

Technological Characteristics

Electromagnetic field-based muscle stimulator. Magnetic field intensity 0-2 T; pulse repetition rate 1-100 Hz; pulse duration 300 μs. Skin-contacting material: Acrylonitrile butadiene styrene (ABS). System includes handles, color touch screen, air switch, and key switch. Powered by AC110V, 60Hz. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for individuals seeking improvement of abdominal tone, strengthening of abdominal muscles, development of firmer abdomen, and strengthening, toning, and firming of buttocks, thighs, calves, and arms.

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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September 6, 2023

Beijing Sano Laser S&T Development Co., Ltd % Heather Wang Consultant Microkn Medical Technology Service (Shanghai) Co.,Ltd. Room 901, No. 889, Pinglu Road, Jing'an District Shanghai (Shanghai Jing'an HUAFA Center) Shanghai, 200435 China

Re: K230024

Trade/Device Name: HI-EMT MAGSHAPE Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: July 25, 2023 Received: July 25, 2023

Dear Heather Wang:

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.

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

Sincerely.

# Tushar Bansal -S

for 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 Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K230024

Device Name HI-EMT MAGSHAPE

Indications for Use (Describe)

- · 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)

| <div> <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> </span>Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> </span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary K230024

# 1. Contact information

#### 1.1. Applicant

Applicant Name: Beijing Sano Laser S&T Development Co., Ltd.

Address: Room 7-201, No.1, Caida 3rd Street, Nancai Town, Shunyi

District, Beijing, China.

Contact Person: Hongbo Zhang

Title: Manager

Tel: [phone]

Email: alex(@sanolasers.com

Date prepared: Dec. 15, 2022

#### 1.2. Consultant

Company: Microkn Medical Technology Service (Shanghai) Co.,Ltd.

Address: Room 901, No. 889, Pinglu Road, Jing'an District,

Shanghai (Shanghai Jing'an HUAFA Center)

Contact Person: Heather. Wang

Telephone: [phone]

Email: [e-mail]

#### 2. Device information

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- Trade Name: HI-EMT MAGSHAPE .
- Classification Name: Stimulator, Muscle, Powered, for Muscle Conditioning ●
- Model(s): SHE-MSP003, SHE-MSP002, SHE-MSP001 ●
- Classification: II ●
- Product Code: NGX ●
- Regulation Number: 21 CFR 890.5850 .

# 3. Indications for Use

- . 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.

# 4. Legally Marketed Predicate Device

Product name: BTL 799-2L

510(k) Number: K190456

Product Code: NGX

Manufacture: BTL Industries, Inc.

#### 5. Description of the device

The proposed device is a type of the most advanced electromagnetic.noninvasive treatment machine (with attachments). It is used for muscle

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tension enhancement and muscle strengthening on abdomen, hips, thighs, arms, etc.

Three models (SHE-MSP003, SHE-MSP002 and SHE-MSP001) are included in HI-EMT MAGSHAPE series products, and they have the same intended purposes, working theories and specifications.

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The main components of proposed device shown in Table 1.

| Components | Functions | Applied to |
|--------------------|--------------------------------------------------------------------|------------|
| Handle | Deliver Electromagnetic Field Energy to<br>Body Part to be Treated | ALL Models |
| Color Touch Screen | User Interface and System Used for<br>Control | ALL Models |
| Air Switch | Protect the System | ALL Models |
| KEY Switch | Start the System | ALL Models |

Table 1 Main Components of Proposed Device

#### 6. Non-Clinical Test conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- IEC 60601-1 Medical electrical device Part1: 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 compatibility- Requirements and tests

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# 7. Clinical Test Conclusion

No clinical study is included in this submission.

# 8. Substantially Equivalent (SE) Comparison

The HI-EMT MAGSHAPE has been carefully compared to legally marketed devices with respect to intended use, configuration, principle of operation (Table 2), performance specifications (Table 3).

| | Proposed Device | Predicate Device | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Item | HI-EMT<br>MAGSHAPE<br>K230024 | BTL 799-2L<br>K190456 | Remark |
| Product<br>Code | NGX | NGX | Same |
| Regulation<br>Number | 21CFR 890.5850 | 21 CFR 890.5850 | Same |
| Indications<br>for Use | • Improvement of<br>abdominal tone,<br>strengthening of the | • Improvement of<br>abdominal tone,<br>strengthening of the | Same |
| Item | Proposed Device<br>HI-EMT<br>MAGSHAPE | Predicate Device<br>BTL 799-2L | Remark |
| | abdominal muscles,<br>development of<br>firmer abdomen.<br>• Strengthening,<br>Toning and Firming<br>of buttocks, thighs<br>and calves.<br>• Improvement of<br>muscle tone and<br>firmness, for<br>strengthening<br>muscles in arms. | abdominal muscles,<br>development of<br>firmer abdomen.<br>• Strengthening,<br>Toning and Firming<br>of buttocks, thighs<br>and calves.<br>• Improvement of<br>muscle tone and<br>firmness, for<br>strengthening<br>muscles in arms. | |
| Principle of<br>Operation | Initiating action<br>potential of nerves<br>results in muscle<br>contraction. | Initiating action<br>potential of nerves<br>results in muscle<br>contraction. | Same |
| Type of use | Prescription use | Prescription use | Same |
| | Proposed Device | Predicate<br>Device | |
| Item | HI-EMT<br>MAGSHAPE | BTL 799-2L | Remark |
| Electronic Protection<br>Class | Class I, Type B | Class II, Type<br>BF | Similar<br>Note 1 |
| User Interface | Touch screen | Touch screen | Same |
| Type of Energy | Magnetic field | Magnetic field | Same |
| Magnetic Field Intensity | 0-2 T | BTL 299-6<br>applicator:<br>0.5 - 1.8<br>T±20%<br>BTL 299-7<br>applicator:<br>0.7 - 2.0<br>T±20% | Similar<br>Note 2 |
| Pulse Repetition Rate | F1:1-10Hz<br>F2:1-100Hz | 1-150 Hz | Similar<br>Note 2 |
| Pulse Duration | 300 μs | BTL 299-6<br>applicator: | Similar<br>Note 2 |
| | Proposed Device | Predicate<br>Device | |
| Item | HI-EMT<br>MAGSHAPE | BTL 799-2L | Remark |
| | | $280 \pm 20\% \mu s$<br>BTL 299-7<br>applicator:<br>$190 \pm 20\% \mu s$ | |
| Selection of<br>parameters (Intensity,<br>Time) | Yes | Yes | Same |
| Therapy Time | Up to 60 min | Up to 60 min | Same |
| Energy Source | AC110V, 60Hz | 100-240 V AC,<br>50-60 Hz | Similar<br>Note 1 |
| System Dimensions<br>(D × W × H) | MSP001: 520 *<br>440 * 1240mm,<br>Tolerance: ≤ ±<br>5%<br>MSP002: 530 *<br>400* 1140mm,<br>Tolerance: ≤ ±<br>5%<br>MSP003: 550 * | 580 × 580 ×<br>1380 mm<br>(23 × 23 × 55<br>in) | Similar<br>Note 3 |
| Item | Proposed Device | Predicate Device | Remark |
| | HI-EMT MAGSHAPE | BTL 799-2L | |
| | 400 * 1140mm,<br>Tolerance: $\leq \pm 5\%$ | | |
| Ambient Temperature | + 16°C ~ + 35°C | -10°C ~ +<br>55°C | Similar<br>Note 4 |
| Relative Humidity | 80%, No<br>Condensation | 10% to 85% | Similar<br>Note 4 |
| Environmental<br>Specifications | For indoor use<br>only | For indoor use<br>only | Same |

Table 2 General Comparison

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# Table 3 Performance Comparison

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#### Note 1

The proposed device HI-EMT MAGSHAPE has minor difference on Electronic Protection Class and Energy Source with the predicate device BTL 799-2L, but the proposed device had passed IEC 60601-1 and IEC 60601-1-2 test codes, so these differences don't raise any new safety and effectiveness issues.

#### Note 2

The proposed device HI-EMT MAGSHAPE has differences on stimulation parameter with the predicate device BTL 799-2L. The differences do not raise new question of safety and or effectiveness.

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#### Note 3

The proposed device HI-EMT MAGSHAPE has minor difference on System Dimensions with the predicate device BTL 799-2L, but differences on appearance design will not affect the effectiveness and performance of the product and will not increase the risk of the product. So, it doesn't raise any new safety and effectiveness issues.

#### Note 4

The proposed device HI-EMT MAGSHAPE has minor difference on Ambient Temperature and Relative Humidity with the predicate device BTL 799-2L, but the proposed device had passed the accelerated aging test, so the difference won't raise any new safety and effectiveness issues.

Safety comparison has been done to validate the EMC specification and safety of the device (Table 4).

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| Item | Proposed Device | Predicate Device | Remark |
|----------------------|------------------------------|------------------------------|--------|
| Electrical<br>safety | Comply with IEC<br>60601-1 | Comply with IEC<br>60601-1 | Same |
| EMC | Comply with IEC<br>60601-1-2 | Comply with IEC<br>60601-1-2 | Same |

Biocompatibility Consideration:

The skin contacting element is Acrylonitrile butadiene styrene (ABS). The biocompatibility of the device was assessed in accordance with FDA's 2020 Biocompatibility Guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'"

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# 9. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.