(60 days)
The device is indicated to be used for:
- · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks and thighs.
The Electromagnetic stimulator device consists of a host, hand tools and power cord. The host contains a power supply unit, a control unit, and a cooling unit. The control unit includes a control element and a liquid crystal display. The hand tools include electromagnetic induction coils and cooling fans, it is a non-invasive therapeutic device.
The subject device has two models, Tesla Duet and EM contouring. The two models are exactly the same except for the color of the host shell, one is black and other is white.
The device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the Electromagnetic stimulator device helps to strengthen, tone and firm the abdomen, buttocks and thighs. The device two outputs enable simultaneous treatment by two applicators.
The Electromagnetic stimulator device is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user step by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen and buttons on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
The provided document is a 510(k) summary for a medical device (Electromagnetic Stimulator Device). It details the device's characteristics and its equivalence to a predicate device. However, it explicitly states "No clinical study is included in this submission" under section 8.0 Clinical Test Conclusion and that "Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness." Therefore, the document does not contain the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria.
The submission focuses primarily on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technological characteristics, rather than reporting on a standalone clinical study with acceptance criteria.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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Image /page/0/Picture/0 description: The image shows 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 the FDA logo, which 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.
July 7, 2023
Beijing ADSS Development Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China
Re: K231318
Trade/Device Name: Electromagnetic Stimulator Device (Models: EM Contouring and Tesla Duet) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: May 8, 2023 Received: May 8, 2023
Dear Mr. Boyle 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 (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-reporting-mdr-howreport-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) 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorywebsite the DICE assistance/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.
| TusharBansal -S | Digitally signed byTushar Bansal -SDate: 2023.07.0714:27:15-04'00' |
|---|---|
| --------------------- | -------------------------------------------------------------------------------- |
for Heather Dean, Ph.D. Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation 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) K231318
Device Name
Electromagnetic Stimulator Device (Model: EM Contouring, Tesla Duet)
Indications for Use (Describe)
The device is indicated to be used for:
- · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
· Strengthening, Toning and Firming of buttocks and thighs.
| 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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 submitter's Information
| Name: | Beijing ADSS Development Co., Ltd. |
|---|---|
| Applicant Address: | Room 609, F6, Building 13, Yard 5 Tianhua Street,Daxing District, Beijing, 102600, P. R. China |
| Production Address: | Fuda Road - Tongsheng Road, Southern Area of IndustrialPark,Gu'an County, 065599 Langfang City, Hebei Province,P.R. China |
| Tel: | 86-13051615111 |
| Contact: | Song Ying |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai,200120 China |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date of Preparation: May.5th,2023
2.0 Device Information
| Trade name: | Electromagnetic Stimulator Device |
|---|---|
| Common name: | Powered muscle stimulator |
| Classification name: | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Model(s): | EM Contouring, Tesla Duet |
| Production code: | NGX |
| Regulation number: | 21CFR 890.5850 |
| Classification: | Class II |
| Panel: | Physical Medicine |
3.0 Predicate and Reference Devices
Predicate Device:
Manufacturer: BTL Industries, Inc.
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| Device: | BTL 799-2 |
|---|---|
| 510(k) number: | K180813 |
Reference Device:
| Manufacturer: | BTL Industries, Inc. |
|---|---|
| Device: | BTL 799-2L |
| 510(k) number: | K190456 |
4.0 Device Description
The Electromagnetic stimulator device consists of a host, hand tools and power cord. The host contains a power supply unit, a control unit, and a cooling unit. The control unit includes a control element and a liquid crystal display. The hand tools include electromagnetic induction coils and cooling fans, it is a non-invasive therapeutic device.
The subject device has two models, Tesla Duet and EM contouring. The two models are exactly the same except for the color of the host shell, one is black and other is white.
The device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the Electromagnetic stimulator device helps to strengthen, tone and firm the abdomen, buttocks and thighs. The device two outputs enable simultaneous treatment by two applicators.
The Electromagnetic stimulator device is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user step by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen and buttons on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
5.0 Indication for Use Statement
The device is indicated to be used for:
- Improvement of abdominal tone, strengthening of the abdominal muscles, . development of firmer abdomen.
- Strengthening, Toning and Firming of buttocks and thighs.
6.0 Comparison to the Predicate Device
Table 6.1: Technological Characteristics between Subject and Predicate Device
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| Item | Subject Device | Predicate Device | Reference Device | Comparison |
|---|---|---|---|---|
| Manufacturer | Beijing ADSS DevelopmentCo., Ltd. | BTL Industries, Inc. | BTL Industries, Inc. | —— |
| 510(k) No. | K231318 | K180813 | K190456 | —— |
| Trade name | Electromagnetic StimulatorDevice | BTL 799-2 | BTL 799-2L | —— |
| Model | EM Contouring, Tesla Duet | BTL 799-2 | BTL 799-2L | —— |
| Regulationnumber | 21 CFR 890.5850 | 21CFR 890.5850 | 21CFR 890.5850 | Same |
| Regulation Name | Powered muscle stimulator | Powered muscle stimulator | Powered muscle stimulator | Same |
| Product code | NGX | NGX | NGX | Same |
| Class | II | II | II | Same |
| Indications foruse/Intended use | The device is indicated tobe used for:· Improvement ofabdominal tone,strengthening of theabdominal muscles,development of firmerabdomen.· Strengthening, Toningand Firming of buttocks | BTL 799-2 is indicated to be used for:· Improvement of abdominal tone,strengthening of the abdominalmuscles, development of firmerabdomen.· Strengthening, Toning andFirming of buttocks and thighs. | BTL 799-2L is indicated to beused for:· Improvement of abdominaltone, strengthening of theabdominal muscles,development of firmerabdomen.· Strengthening, Toning andFirming of buttocks, thighsand calves. | Same |
| and thighs. | Improvement of muscletone and firmness, forstrengthening muscles inarms. | |||
| Location for use | Prescription Use | Prescription Use | Prescription Use | Same |
| Primary Function | Muscle stimulation | Muscle stimulation | Muscle stimulation | Same |
| Principle of Action | Initiating action potential of nerves results in muscle contraction | Initiating action potential of nerves results in muscle contraction | Initiating action potential of nerves results in muscle contraction | Same |
| Electrical Protection | Class II, BF | Class II, BF | Class II, BF | Same |
| User Interface | Touch screen | Touch screen | Touch screen | Same |
| Touch screen size | 15.6" (39.6 cm) | 15.6" (39.6 cm) | 15.6" (39.6 cm) | Same |
| Firmware Controlled | Yes | Yes | Yes | Same |
| Type of Energy | Magnetic field | Magnetic field | Magnetic field | Same |
| Number of outputs | 2 | 2 | 2 | Same |
| Number of Magnetic Coils in the Applicator | 1 | 1 | 1 | Same |
| Number of Magnetic coils | 1 | 1 | 1 | Same |
| in the | ||||
| Applicator | ||||
| ApplicatorDimensions | 252.3167.396mm(±0.2mm) | Not publicly available | Not publicly available | — |
| Surface Area | Surface Area of theTreatmentprobe:13471.4mm²Surface Area of theApplicator: 33257.7mm² | Not publicly available | Not publicly available | — |
| Magnetic FieldIntensity (onthe coilsurface) | 0.5-1.8T,±20% | 299-6 applicator: 0.5-1.8 T | BTL 299-6 applicator:0.5 - 1.8 T , ±20%BTL 299-7 applicator:0.7 - 2.0 T , ±20% | Same |
| MaximumMagnetic FieldIntensity atApplicatorCenterSurface | 1.0T±20% | BTL 299-6 applicator:1.154 T±20%; | BTL 299-6 applicator:1.154 T±20%;BTL 299-7 applicator:1.173 T±20%. | The maximum field intensity atApplicatorCenter Surface is 1.0T ascompared to the 1.154T of thepredicate device. However, themagnetic field intensity is within therange of the predicate device. |
| Induced Currentin the Tissue | 20.6mA | 28-30 mA | Not publicly available | The induced current on the tissuefor the subject device is less thanthe predicate device and thereforesafer with the same effect. |
| Type ofOperation | Continuous | Continuous | Continuous | Same |
| Pulse RepetitionRate | 1 – 150 Hz | 1 – 150 Hz | 1 – 150 Hz | Same |
| Pulse Duration | 270 ±20% μs | 280 ± 20% μs | BTL 299-6 applicator:280 ± 20% μs;BTL 299-7 applicator:190 ± 20% μs | The subject device has little shorter pulse width when compared to the predicate device but in the range between the predicate and reference device. |
| Pulse Amplitude | 0 – 100%, step 1% | 0 – 100% | Not publicly available | Same |
| Selection ofparameters(Intensity, Time) | Yes | Yes | Yes | Same |
| Shape ofStimulationPulse | Symmetrical Biphasic SineWave | Symmetrical Biphasic SineWave | Symmetrical Biphasic SineWave | Same |
| Therapy Time | 1-60min | Up to 60 min | Up to 60 min | Same |
| Application | Hands-free, applicator fixed by fixation belt | Hands-free, applicator fixed by fixation belt | Hands-free, applicator fixed by fixation belt | Same |
| Energy Source | 100–240 VAC, 50–60 Hz | 100 - 240 V AC, 50-60 Hz | 100 - 240 V AC, 50-60 Hz | Same |
| SystemDimensions(W×H×D) | 525×433×1279mm/640×560×1390mm | 500×1380×580 mm(20×55×23 in) | 580×1380×580 mm(23×55×23 in) | Different dimensions have no influence on the safety or effectiveness of the device. |
| AmbientTemperature | -20°C~+55°C | -10°C to +55°C | -10°C to +55°C | This difference has no influence on the safety or effectiveness of the device. |
| EnvironmentalSpecifications | For indoor use only | For indoor use only | For indoor use only | Same |
| ConformanceStandard | IEC 60601-1;IEC 60601-1-2;IEC 60601-1-6;IEC 60601-1-9;IEC 60601-2-10 | IEC 60601-1;IEC 60601-1-2;IEC 60601-1-6;IEC 60601-2-10 | IEC 60601-1;IEC 60601-1-2;IEC 60601-1-6;IEC 60601-2-10 | Same |
| Patient contactmaterial | Hand Tool: ABS&PC | Not publicly available | Not publicly available | Biocompatibility evaluation for bothsubjectdevicethetheandpredicate device. The differenceaffectdoesnotsafetyandeffectiveness. |
| Biocompatibility | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | Same |
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7.0 Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the subject devices met all design specifications as were Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
● ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment -- Part 1: General Requirements for Basic Safety and essential performance
● IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
● IEC60601-2-10:2016, Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
· IEC 60601-1-6: 2013, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
● IEC 60601-1-9:2007+A1:2013, Medical electrical equipment- Part 1-9: General requirements for basic safety and essential performance Collateral Standard: Requirements for environmentally conscious design
● ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
● ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Software Information:
Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
8.0 Clinical Test Conclusion
No clinical study is included in this submission.
9.0 Conclusion
Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness. And based on the performance testing and compliance with acceptable voluntary standards, we believe the subject device is substantially equivalent to its predicate device.
§ 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).