(245 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the device description focuses on electromagnetic technology for muscle stimulation.
Yes
The device is intended for "improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen," and "strengthening, toning and firming of buttocks, thighs and calves," which are therapeutic effects on the body.
No
The device description and intended use clearly state that it is for muscle strengthening, toning, and firming. There is no mention of it being used to diagnose conditions or diseases.
No
The device description explicitly states it is an "electromagnetic noninvasive treatment machine (with attachments)" and mentions testing against hardware standards (IEC 60601-1, IEC 60601-1-2), indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use of this device clearly state that it is an electromagnetic noninvasive treatment machine used for muscle tension enhancement and strengthening on various parts of the body (abdomen, hips, thighs, arms, calves, buttocks). It works externally on the body.
- Lack of Mention of Samples or Testing: There is no mention of collecting or analyzing samples from the body, which is a core characteristic of IVDs.
Therefore, this device falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
NGX
Device Description
The proposed device is a type of the most advanced electromagnetic.noninvasive treatment machine (with attachments). It is used for muscle 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen, buttocks, thighs, calves, arms, hips
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 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
No clinical study is included in this submission.
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: +86 10 53006037-830
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: +86 13166194697
Email: heather.wang@microkn.com
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 | |
| Body Part to be Treated | ALL Models | |
| Color Touch Screen | User Interface and System Used for | |
| 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 | ||
| MAGSHAPE | |||
| K230024 | BTL 799-2L | ||
| K190456 | Remark | ||
| Product | |||
| Code | NGX | NGX | Same |
| Regulation | |||
| Number | 21CFR 890.5850 | 21 CFR 890.5850 | Same |
| Indications | |||
| for Use | • Improvement of | ||
| abdominal tone, | |||
| strengthening of the | • Improvement of | ||
| abdominal tone, | |||
| strengthening of the | Same | ||
| Item | Proposed Device | ||
| HI-EMT | |||
| MAGSHAPE | Predicate Device | ||
| BTL 799-2L | Remark | ||
| 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. | 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. | |||
| Principle of | |||
| Operation | Initiating action | ||
| potential of nerves | |||
| results in muscle | |||
| contraction. | Initiating action | ||
| potential of nerves | |||
| results in muscle | |||
| contraction. | Same | ||
| Type of use | Prescription use | Prescription use | Same |
| Proposed Device | Predicate | ||
| Device | |||
| Item | HI-EMT | ||
| MAGSHAPE | BTL 799-2L | Remark | |
| Electronic Protection | |||
| Class | Class I, Type B | Class II, Type | |
| BF | Similar | ||
| 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 | |
| applicator: | |||
| 0.5 - 1.8 | |||
| T±20% | |||
| BTL 299-7 | |||
| applicator: | |||
| 0.7 - 2.0 | |||
| T±20% | Similar | ||
| Note 2 | |||
| Pulse Repetition Rate | F1:1-10Hz | ||
| F2:1-100Hz | 1-150 Hz | Similar | |
| Note 2 | |||
| Pulse Duration | 300 μs | BTL 299-6 | |
| applicator: | Similar | ||
| Note 2 | |||
| Proposed Device | Predicate | ||
| Device | |||
| Item | HI-EMT | ||
| MAGSHAPE | BTL 799-2L | Remark | |
| $280 \pm 20% \mu s$ | |||
| BTL 299-7 | |||
| applicator: | |||
| $190 \pm 20% \mu s$ | |||
| Selection of | |||
| parameters (Intensity, | |||
| Time) | Yes | Yes | Same |
| Therapy Time | Up to 60 min | Up to 60 min | Same |
| Energy Source | AC110V, 60Hz | 100-240 V AC, | |
| 50-60 Hz | Similar | ||
| Note 1 | |||
| System Dimensions | |||
| (D × W × H) | MSP001: 520 * | ||
| 440 * 1240mm, | |||
| Tolerance: ≤ ± | |||
| 5% | |||
| MSP002: 530 * | |||
| 400* 1140mm, | |||
| Tolerance: ≤ ± | |||
| 5% | |||
| MSP003: 550 * | 580 × 580 × | ||
| 1380 mm | |||
| (23 × 23 × 55 | |||
| in) | Similar | ||
| Note 3 | |||
| Item | Proposed Device | Predicate Device | Remark |
| HI-EMT MAGSHAPE | BTL 799-2L | ||
| 400 * 1140mm, | |||
| Tolerance: $\leq \pm 5%$ | |||
| Ambient Temperature | + 16°C ~ + 35°C | -10°C ~ + | |
| 55°C | Similar | ||
| Note 4 | |||
| Relative Humidity | 80%, No | ||
| Condensation | 10% to 85% | Similar | |
| Note 4 | |||
| Environmental | |||
| Specifications | For indoor use | ||
| only | For indoor use | ||
| 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 | |||
| safety | Comply with IEC | ||
| 60601-1 | Comply with IEC | ||
| 60601-1 | Same | ||
| EMC | Comply with IEC | ||
| 60601-1-2 | Comply with IEC | ||
| 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.