EMS Sculpt Machine

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration". November 25, 2024 Shandong Huamei Technology Co., Ltd. Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, Beijing 102401 China Re: K232982 Trade/Device Name: EMS Sculpt Machine Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: March 25, 2024 Received: March 25, 2024 ## Dear Ray 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 (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. {1}------------------------------------------------ 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" (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 QS 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 Rule"). 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-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-regulatory {2}------------------------------------------------ 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, # Heather L. Dean -S 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K232982 Device Name EMS Sculpt Machine ### Indications for Use (Describe) The EMS Sculpt Machine 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) | <span style="font-family: Arial;"> <svg height="10" width="10"> <rect height="10" style="fill:lightgray;stroke-width:1;stroke:rgb(0,0,0)" width="10"></rect> <line style="stroke:rgb(0,0,0);stroke-width:1" x1="0" x2="10" y1="0" y2="10"></line> <line style="stroke:rgb(0,0,0);stroke-width:1" x1="0" x2="10" y1="10" y2="0"></line> </svg> Prescription Use (Part 21 CFR 801 Subpart D)</span> | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <span style="font-family: Arial;"> <svg height="10" width="10"> <rect height="10" style="fill:white;stroke-width:1;stroke:rgb(0,0,0)" width="10"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C)</span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary K232982 #### Date of Preparation: 09/15/2023 #### Sponsor Identification Shandong Huamei Technology Co.,Ltd. 588, Changning Street, High-tech District, Weifang, Shandong 261205 People's Republic of China. Contact Person: DongYugui Position: vice-general manager Tel: +86-15306469955 Fax: +86-536-2109823 Email: 2851353667@qq.com #### Designated Submission Correspondent Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China, 102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: information(@believe-med.com #### Device: Trade name: EMS Sculpt Machine Common name: Powered muscle stimulator #### Regulatory Information Classification Name: Stimulator, Muscle, Powered, For Muscle Conditioning Classification: Class 2 Product Code: NGX Regulation Number: 21 CFR 890.5850 Regulation Name: Stimulator, Muscle, Powered, For Muscle Conditioning Review Panel: Physical Medicine #### Predicate Device(s) Primary Predicate Device 510(k) Number: K163165 Product Name: AM-100 Manufacturer: BTL Industries, Inc. Classification: Class 2 Product Code: NGX Regulation Number: 21 CFR 890.5850 #### Indication For Use Statement: The EMS Sculpt Machine 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. {5}------------------------------------------------ #### Device Description The EMS Sculpt Machine is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the EMS Sculpt Machine helps to strengthen and firm the abdomen, buttocks and thighs. The EMS Sculpt Machine is equipped with a LCD touch screen that significantly facilitates the use of the device. The user exchanges with the system by the LCD and the keys on it. The state of the system, the operation interface, the instructions and hints to the user will be shown on the LCD. #### 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: - > ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, 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 - > IEC 60601-2-10:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators - > IEC 60601-1-6:2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability - > ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - > ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization - A ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation #### Clinical Test Conclusion No clinical study is included in this submission. {6}------------------------------------------------ # Technological Characteristics Table 1 General Comparison | ITEM | Proposed Device | Predicate Device (K163165) | Remark | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Indications for use | The EMS Sculpt Machine 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 and thighs. | AM-100 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 and thighs. | SAME | | Product Code | NGX | NGX | SAME | | Regulation Number | 21 CFR 890.5850 | 21 CFR 890.5850 | SAME | | Regulation Name | Stimulator, Muscle, Powered, For Muscle<br>Conditioning | Stimulator, Muscle, Powered, For<br>Muscle Conditioning | SAME | | Classification | II | II | SAME | | Prescription vs. OTC | Prescription use | Prescription use | SAME | | Principle of Action | Initiating action potential of nerves results in<br>muscle contraction | Initiating action potential of nerves<br>results in muscle contraction | SAME | | User Interface | Touch screen | Touch screen | SAME | | Type of Energy | Magnetic field | Magnetic field | SAME | | Firmware Controlled | YES | YES | SAME | | Environmental<br>Specifications | For indoor use only | For indoor use only | SAME | | Magnetic Field<br>Intensity | HM-P handle:0.1-2.5T<br>HM-C handle:0.1-2T | Applicator 299-1: 0.5–1.8 T<br>Applicator 299-2: 0.7-2.5 T | Analyze 1 | | Type of Operation | Continuous | Continuous | SAME | | Pulse Frequency | 1-150Hz | 1-150Hz | SAME | | Pulse Duration | $280 \pm 20\% \mu s$ | $280 \pm 20\% \mu s$ | SAME | | Pulse Amplitude | 0-100% | 0 - 100% | SAME | | Induced Current in<br>the Tissue | 28-30mA | 28-30 mA | SAME | | Selection of<br>parameters (Intensity,<br>Time) | YES | YES | SAME | | Therapy Time | Up to 30 min | Up to 60 min | Analyze 2 | | Shape of Stimulation<br>Pulse | Bidirectional wave | Bidirectional wave | SAME | | Energy Source | 100~240VAC,50/60Hz | 100 - 240 VAC, 50-60 Hz | SAME | | System Dimensions<br>(W×H×D) | 497.5×1109×615mm | 500×970×580 mm (20×38×23 in) | Analyze 3 | | Ambient<br>Temperature | -10°C~55°C | -10°C to +55°C | SAME | | Environmental<br>Specifications | For indoor use only | For indoor use only | SAME | | Applied Standards: | | | | | Biocompatibility | ISO 10993-1, ISO 10993-5,<br>ISO 10993-10, ISO 10993-23 | NA | Analyze 4 | | Electrical Safety | IEC 60601-1 and IEC 60601-1-6 | IEC 60601-1 and IEC 60601-1-6 | SAME | | EMC | IEC 60601-1-2 | IEC 60601-1-2 | SAME | | Performance | IEC 60601-2-10 | IEC 60601-2-10 | SAME | {7}------------------------------------------------ #### Analyze 1: The Magnetic Field Intensity of subject device is 0.1-2.5T, The max Magnetic Field Intensity is same to the predicate device and no new risk arises. Both of them meet the requirements of IEC 60601-1-2 and IEC 60601-2-10, so we believe that this difference will not raise any risks in safety and effective, both the proposed device and predicate device are safe and effective. #### Analyze 2: The treatment of proposed device is between 0~30 min, it is less than predicate device. The high temperature risk is lower than predicate device. Both of them meet the requirements of IEC 60601-2-10, so we believe that this difference will not raise any risks in safety and effective, both the proposed device and predicate device are safe and effective. #### Analyze 3: The proposed device is different in System Dimensions from the predicate device. However, the configuration difference is just in physical specification and this difference will not raise any issues in safety and effectiveness. By complying with IEC 60601-1, the mechanical performance of the proposed device is determined to be accepted. Therefore, this difference will not affectiveness of the proposed device. #### Analysis 4: The proposed device is different in Biocompatibility Testing Standard from the predicate device (K163165). We tested ISO 10993-5:2009, ISO 10993-10:2021 and ISO 10993-23:2021, which are FDA recognized standard. Therefore, this difference will not affect the safety in Biocompatibility of the proposed device. {8}------------------------------------------------ # Conclusion Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K163165).